FDA Adverse Event Injury Summary report: N

TMJ SOLUTIONS

MDR report key: 2296537 · Received October 7, 2011

Report

Report Number
MW5022611
Event Type
Injury
Date Received
October 7, 2011
Date of Event
March 9, 2009
Report Date
October 7, 2011
Manufacturer
TMJ SOLUTIONS
Product Code
LZD
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD THE CHRISTENSEN TMJ ALL METAL JOINTS FOR ELEVEN YEARS AND NEVER HAD ANY PROBLEMS UNTIL THEY WORE OUT. I HAD THEM REPLACED, (B)(6) 2009 WITH (B)(6) CONCEPTS CUSTOM JOINTS BY DR. (B)(6) AT THE UNIVERSITY (B)(6). TMJ CUSTOM IMPLANTS DIDN'T FIT RIGHT SO THE DOCTOR HAD TO SAW MY JAW BONE TO MAKE IT FIT DURING MY SURGERY, ADDING AND ADDITIONAL HOUR TO MY SURGERY. I BELIEVE THE IMPLANTS WERE CONTAMINATED WITH (B)(6) AND THAT THE CONTAMINATION OCCURRED AT TMJ CONCEPTS' FACTORY. I HAD FIVE PIC LINES WHILE AT THE HOSPITAL AND NEARLY DIED. ON (B)(6) 2009, DR. (B)(6), (B)(6) ASSOCIATE REMOVED MY LEFT TMJ CONCEPTS IMPLANT DUE TO (B)(6). THE IMPLANTS WERE COVERED IN (B)(6). SIX MONTHS LATER, I HAD TO HAVE THE RIGHT TMJ CONCEPTS DEVICE REMOVED BY A DIFFERENT DOCTOR BECAUSE THE UNIVERSITY (B)(6) WOULD NO LONGER TREAT ME. AFTER THE DEVICE WAS REMOVED, I NO LONGER HAD ANY PROBLEMS. I DISCOVERED THAT A MEDWATCH REPORT REGARDING MY CASE WAS NEVER FILED BY THE MANUFACTURER OR THE PHYSICIAN. I SPOKE WITH AN FDA OFFICIAL AND WAS TOLD SOMEONE WOULD GET BACK TO ME AND THEY NEVER DID. DURING ALL OF THIS, I LOST (B)(6). TODAY, I HAVE NO JAWS AND MY CURRENT OPENING IS 4-5 MM. I AM (B)(6) AND I LOOK LIKE I'M 80. THIS SURGERY CHANGED MY WHOLE LIFE. I CAN'T GO OUT AND EAT LIKE A NORMAL PERSON; EVERY TIME I EAT, I HAVE TO TAKE OXYCODONE. THIS DEVICE ALMOST COST ME MY LIFE AND I WENT THROUGH PURE HELL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TMJ SOLUTIONS TMJ CONCEPTS CUSTOM DEVICE LZD TMJ SOLUTIONS

Patients

Seq Age Sex Outcome Treatment
1 56 YR Hospitalization| L| O| R| S