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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Spinal Concepts, Inc. 21-Jun-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Dallas District
4040 North Central Expressway
Dallas. Texas 75204-3145

June 21, 2004

Ref: 2004-DALWL-20



Mr. Jeffrey R. Binder
Chief Executive Officer and President
Spinal Concepts, Inc.
5301 Riata Park Court, Bldg F
Austin, Texas 70727-3436

Dear Mr. Binder:

On February 5-6 and 9-12, 2004, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your facility, which manufactures the BacFix® Thoracolumbar System (the BacFix), the Harmonym PLIF Instrument Set, and the Cadence” Vue vertebral body replacement device, which are medical devices under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h).

The inspection revealed that these products are adulterated within the meaning of section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current Good Manufacturing Practice (cGMP) requirements set forth in FDA’s Quality System (QS) Regulation, codified in Tiie 21, Code of Federal Regulation (CFR), Part 820.

The investigator noted the following QS Regulation violations, which are also listed in the FDA Form 483 provided to your facility at the end of the inspection:

1. Failure to maintain complaint fifes and to establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 820.198. Specifically, your firm received numerous complaints regarding breakage of the coldwelder instrument that is part of a kit of tools intended for use in irriplanting the BacFix, but your complaint files do not contain complete information about these complaints.

2. Failure to establish and maintain procedures for implementing corrective and preventive action that include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). In April 2002, after receiving complaints of tip breakage, your firm redesigned the coldwelder by, changing the stainless steel material from [redacted] to [redacted]. The design change was intended to increase the metal fatigue strength. After your firm received additional complaints of tip breakage in the new parts, you changed the material back to [redacted] with additional minor adjustments to dimensional specifications to reduce gauling. The reason for this change was that you believed stainless steel [redacted] had a problem with corrosion. However, according to a problem detail report (Action No. 13, August 1, 2002), your firm then determined that the tip breakages might not have been caused by corrosion, and that a third change might be necessary. Your firm did not verify or validate these design changes to ensure that they are effective and do not adversely affect the finished coldwelder.

3. Failure to establish and maintain procedures for rework (including retesting and reevaluation of the nonconforming product after rework) .to ensure that the product meets its current approved specifications, and to document rework and reevaluation activities (including a determination of any adverse effect from the rework upon the product) in the device history record, as required by 21 CFR 82090(b)(2). Your firm reworked two nonconforming parts (955-4 and 955-5) to the design specifications of two new parts (955-7 and 9558), but did not demonstrate how the nonconforming parts were reworked and retested to meet the design specifications of the new parts and did not document a determination of any adverse effect from the rework.

4. Failure to estabtish and maintain procedures for implementing corrective and preventive action that include requirements for investigating the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2), and to document all required corrective and preventive action activities and their results, as required by 21 CFR 820.100(b). Specifically, your firm failed to document that it investigated whether coldwelderparts were being incorrectly heat treated, as described in problem detail reports (Action No. II, closed June 5, 2002, and Action No. 12, closed June 10, 2002).

5. Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the results of an evaluation of their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm discovered that the test parts manufactured by [redacted] were incorrectly heat treated to [redacted] instead of the specified [redacted] but did not explain the type and extent of controls your firm has exercised over this contract manufacturer to-ensure that this problem will not recur.

6. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70. Specifically, your firm failed to demonstrate that the heat treatment process for the coldwelder instrument has been verified to assure that ail metal parts were heat treated consistently and met specifications.

7. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). Specifrrlly, your firm has not established a written design and development plan for the Cadence device.

8 Failure to establish and maintain device design validation procedures that (1) ensure that devices conform to defined user needs and intended uses and (2) include testing of production units under actual or simulated use conditions, as required by 21 CFR 82030(g). Specifically, with respect to the coldwelder instrument, although these instruments must be autocl use, your firm did not subject the new parts 9557/8 (stainless steel [redacted] to autoclave sterilization testing to detect corrosion cracking. In addition, the fatigue testing performed on the coldwelder instrument did not subject the test parts to non-linear motions surgeons are expected to perform, such as twisting, turning, and opening the jaw of the coldwelder at various angles to press fit the rod to the wedge/screw assembly. Nor did your firm explain how the fatigue life expectancy data generated during a mechanical load test is equivalent to the actual fatigue life expectancy experienced during surgery. With respect to Cadence, your firm did not consider the effect of [redacted] which is an actual use condition, on conform of the device with its specifications, and did not study the strength of the [redacted] material used in this device outside nominal conditions.

This letter is not intended to be an all-indusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each applicable requirement of the Act and FDA regulations. The specific violations noted in this letter and in the Form FDA-483 may be symptomatic of serious underlying problems in your firm’s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective actions and preventative action on your quality system.

Federal agencies are advised of the issuance of ail Warning Letters about devices so that they may take this information into account when considerihg the award of contracts. Additionally, no applications for premarket approval of Class Ill devices to which the QS Regulation deficiencies are reasonably related will be approved until the violations have been corrected.

Failure to promptly correct these violations may result in the initiation of FDA regulatory action without further notice. These actions include, but are not limited to, seizure,
injunction, and/or civil penalties.

We acknowledge receiving your letters dated February 20, 2004, and June 1, 2004, responding to the Form FDA-483, and continue to review them. To the extent that the letters do not address the deviations described above, please provide to this office in writing within 15 working days of receipt of this letter a report of the specific steps you have taken, or will take to identify and correct those problems and to assure that they and similar violations will not recur. If corrective action cannot be completed within 15
working days, state the reason for the delay and the time frame within which the corrections will be completed. Your reply should be directed to Thao Ta, Compliance Officer, at the letterhead address.


Michael A. Chappell
Dallas District Director