FDA Adverse Event Injury Summary report: N

TMJ CONCEPTS

MDR report key: 3580969 · Received January 13, 2014

Report

Report Number
MW5033880
Event Type
Injury
Date Received
January 13, 2014
Date of Event
December 31, 2013
Report Date
January 12, 2014
Manufacturer
TMJ SOLUTIONS
Product Code
LZD
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2010, I HAD TMJ CONCEPT DEVICE PUT IN BILATERALLY DUE TO ALKALOSIS OF THE JOINTS AND CHRONIC PAIN OF THE TMJ'S SINCE 1990. RIGHT AFTER SURGERY, I NOTICED WHITEHEADS ALL OVER MY INCISION ON THE ONE SIDE. THE DOCTOR TESTED IT AND FOUND P. ACNES. IT WAS BELIEVED TO JUST BE NORMAL SKIN BACTERIA AND NOT A CAUSE FOR ALARM. I ALSO COULD NOT HEAR OUT OF THIS EAR. MY ENT FOUND PIECES OF BONE IN THE EAR. THESE WERE REMOVED WITH A SPECIAL TOOL. THEY APPEARED TO BE DISEASED BONE THAT WAS BLACK (POSSIBLY FROM BLOOD) I AM NOT SURE IF THEY WORKED THEIR WAY THROUGH FROM TMJ TO EAR CANAL THROUGH THE MEMBRANE THAT SEPARATED IT OR HOW GOT THERE AND IF THIS WAS THE CAUSE OF THE INFECTION. I REGAINED MY HEARING BUT CONTINUED HAVING PAIN, DECREASED MOVEMENT AND WHAT APPEARED TO BE DRAINING FROM THE EAR. I KEPT GETTING SINUS, EAR AND OTHER INFECTIONS THE ENTIRE TIME. I WAS ON ANTIBIOTICS ALMOST EVERY 3 WEEKS. MY SYMPTOMS WOULD DECREASE WHILE ON ANTIBIOTICS BUT WOULD QUICKLY RETURN AFTER STOPPING. MY MASTOID BONE BECAME INFECTED AND THE PAIN INCREASED AS TIME WENT ON. I HAD A LARGE LUMP UNDER THE JAWBONE THAT WOULD GET HARD AND PAINFUL IF I WAS NOT ON ANTIBIOTICS. I STARTED HAVING PAIN ON THE AFFECTED SIDE IN THE SHOULDER, HIP, WRIST, ARM, BACK AND KNEE. I FELT TINGLING ALL ALONG THE AFFECTED SIDE OF THE FACE AND SKULL. IN (B)(6) 2013, I DEVELOPED A FACIAL PALSY THAT LOOKED LIKE BELLS PALSY. THE NEUROLOGIST SAID IT WAS PROBABLY THE JOINT. THE IMPLANTING SURGEON SCHEDULED EXPLORATORY OPEN JOINT TO TAKE SAMPLES AROUND THE IMPLANT AND FOUND STAPH COAG NEGATIVE AND P. ACNES. FROM (B)(6) 2013 - EXPLANT IN (B)(6) 2013, I REMAINED ORAL ANTIBIOTICS. THE JOINT PAIN CONTINUED ON THE AFFECTED SIDE AND WORSENED. ORTHOPEDICS AND FAMILY DOCTOR COULD FIND NOTHING WRONG WITH THE OTHER JOINTS THAT WERE CAUSING PAIN AND STIFFNESS. I BECAME VERY TIRED AND PAIN WAS SEVERE. MY MASSAGE THERAPIST TOLD ME LYMPH NODE CHAINS WERE SWOLLEN ALL ALONG THE AFFECTED SIDE ALL THE WAY DOWN TO MY GROIN. IN (B)(6) 2013, THE ENTIRE IMPLANT, ON THE AFFECTED SIDE WAS EXPLANTED AND ARCH BARS PLACED WITH SCREWS TO KEEP THE BITE STABLE. PICC LINE WITH DAPTOMYCIN PLACED AT EXPLANT AND WILL REMAIN UNTIL 2 WEEKS A NEW JOINT IS PLACED. AN INFECTIOUS DISEASE DOCTOR IS DOING WEEKLY LABS AND TREATING INFECTION AS A TEAM WITH THE (B)(6). THE LAB CULTURED THE SCREWS, UPPER, LOWER PROSTHETIC AND NECROTIC LYMPH NODE AND TISSUE. THEY FOUND (B)(6) AND P. ACNES ON THESE SITES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
22309 TMJ CONCEPTS TMJ CONCEPTS LZD TMJ SOLUTIONS

Patients

Seq Age Sex Outcome Treatment
1 45 YR Hospitalization| L| O| R| S