- Vertebral Technologies, Inc.
- Issuing Office:
- Minneapolis District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
September 4, 2015
Via UPS Overnight Delivery
Refer to MIN 15 – 16
Jeffrey C. Felt, M.D.
Chairman & Chief Executive Officer
Vertebral Technologies, Inc.
5909 Baker Road, Suite 550
Minnetonka, Minnesota 55345
Dear Dr. Felt:
During an inspection of your firm located in Minnetonka, Minnesota, from January 28 through February 2, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures various models of intervertebral body fusion devices, including the InterFuse L, S, and T Intervertebral Body Fusion Devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Our inspection revealed that the InterFuse S Intervertebral Body Fusion Device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and Title 21, Code of Federal Regulations, (21 CFR) Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
1. Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned, and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
For example, complaints CIR numbers 2011-001, 2011-002, 2011-003, 2011-007 and 2009-006 describe events where your firm’s device malfunctioned after implantation. There is no information in the complaint files to justify that a malfunction of the long term implantable device would not be likely to cause or contribute to a reportable death or serious injury, if it were to recur. An MDR should have been submitted for each of the referenced complaints.
2. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17(a).
After reviewing your firm’s MDR procedure entitled “SOP 024, Complaint Handling,” Revision: D, DCO: 2009-030, dated 3/19/09, which was collected during the inspection, the following issues were noted:
A. SOP 024, Complaint Handling, Revision: D, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure omits the definitions of the terms “become aware” and “caused or contributed” found in 21 CFR Part 803.3. The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
B. SOP 024, Complaint Handling, Revision: D, does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
(1) The procedure does not contain or refer to instructions for how to obtain and complete the FDA 3500A form.
(2) The circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports.
(3) Page 7 of the procedure refers to 10-day reporting. This reporting timeframe does not apply to MDR and should be removed. Your firm should visit 21 CFR Part 803 “Medical Device Reporting” Subpart E for references to the mandatory reporting timeframes for manufacturers at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803
(4) The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
Your firm’s procedure includes references to baseline reports. Baseline reports are no longer required and we recommend that all references to a Baseline Report be removed from the firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule took effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to Melissa I. Michurski, Compliance Officer, at the address on the letterhead. If you have any questions about the content of this letter please contact Ms. Michurski at (612) 758-7185.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Michael Dutcher, DVM
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