Inspections, Compliance, Enforcement, and Criminal Investigations
TMJ Implants Inc., Company Response
December 28, 2006
Mr. Ronald L. Swann, Chief
Dental, Ear, Nose Throat, and Ophthalmic Devices Branch (HFZ-331)
Division of Enforcement A
Office of Compliance
Center for Devices and Radiological Health
U.S. Food and Drug Administration
2098 Gaither Road Rockville, Maryland 20850
Re: Warning Letter for Information Appearing on TMJI's Website.
Dear Mr. Swann:
This is a reply to the Warning Letter sent to me by Mr. Timothy Ulatowski dated December 20, 2006, received by our office on December 26, 2006 concerning the referenced matter.
First of all, I want to state for the record that we feel we are in total compliance with the terms and conditions of the prior PMA approval for the use of our Metal-on-Metal Total TMJ Replacement System™ and for the Fossa-Eminence Prosthesis in this situation.
We are sorry if there is a misconception on our website concerning the promotion of our Patient-Specific™ devices, which give the impression that we are "promoting hemi and full mandibles without pre-market clearance or approval from the FDA"
In attempting to reach the public with the awareness of the ability of our Patient-Specific™ full and partial TMJ devices to address complicated conditions that have no other means of solution because of such things as developmental abnormalities which include the Treacher-Collins and Goldenhar Syndromes and other situations of pathological lesion or origin, we should have made it clear that these unusual TMJ conditions are adaptable to treatment with our uniquely designed Patient-Specific™ TMJ devices
Obviously, we do not want to give the impression that we are in the business of"promoting hemi and full mandibles" when our business is the manufacture of devices needed for solving problems with the TMJ.
We will accordingly correct our website to eliminate any doubt or confusion that our labeling reflected on our website is solely to indicate the use of our Patient-Specific™ TMJ devices to address the type of situations approved by the FDA in our PMA.
We hope that this explanation satisfactorily responds to your concerns, as we wish to be in full compliance with FDA's approval for these Patient-Specific™ situations. We will await your response to let us know of any further action which we need to take.
TMJ IMPLANTS, INC.
Robert W. Christensen, DDS, FAIMBE
January 5, 2007
Mr. Timothy A. Ulatowski
Director, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
2094 Gaither Road Rockville, MD 20877
Via e-mail firstname.lastname@example.org
And via fax: 240-276-0101
Re: December 20. 2006 Warning Letter
Dear Mr. Ulatowski:
This is in further reply to your letter of December 20, 2006 and supplements my letter of December 28, 2006. I am disappointed that your office simply did not call me on September 5, 2006, when you reviewed our Internet website. The concern you express in your letter could have been easily explained and addressed to mutual satisfaction. I appreciate that you are aware that we have received marketing approval for the TMJ (Temporomandibular Joint) Metal-On-Metal Joint Replacement System and we believe that our claims for use are consistent with the approval for the PMA. This approval applies to reconstruction of the TMJ due to trauma, developmental abnormality or pathologic lesion to mention a few.
As explained in my letter of December 28, 2006, to Mr. Swan, our devices are intended for use in "solving problems with the TMJ" and not for "promoting hemi and full mandibles ." We regret that the choice of words which have been used in our web site could have been misunderstood, because our intent has always been to associate use of our devices to use for TMJ conditions consistent with the very name of our company. Our web site was revised immediately as it could have been corrected to mutual satisfaction on September 5, 2006, through a telephone call or e-mail.
For your future reference, the "unusual conditions" such as Treacher-Collins and Goldenhar Syndromes relate directly to the TMJ, and for which our devices must be made to conform to the unique features of the patient's anatomy. Very recently, we provided our TMJ device for surgical implantation in a 28-year-old Goldenhar Syndrome patient. This 11 hour surgery was performed, in my presence, through surgeons and a hospital who, along with our company, donated our services. As confirmation of this experience, I attach visuals of the devices supplied by TMJ Implants Incorporated and the procedure itself. If there is any disagreement about our ability to lawfully provide service such as this, I request clarification from your office.
Finally, because the Warning Letter has been made available through the FDA web site, even though fifteen (15) working days have not elapsed since our December 26, 2006, receipt, I request that this letter with attachments and my letter of December 28, 2006 appear for immediate access in the "Response Posted" columns associated with FDA identification of the columns associated with FDA identification of the December 20,2006 Warning Letter.
TMJ IMPLANTS. INC.
Robert Christensen, DDS, FAIMBE
Enclosures Cc: Swan