FDA.reportPublic FDA data

MAUDE MDR 1477461

MDR report key
1477461
Report number
MW5012770
Event key
0
Event type
3
Date of event
2009-09-15
Date received
2009-09-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TMJ CONCEPTSTMJ CONCEPTSTMJ CONCEPTSJAZ Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-09-1501. H; 2. L; 3. O; 4. R

Event Narratives#

D

Patient 1

IN 2008, GOT TMJ CONCEPTS. RECENTLY HAD AN INFECTION AND HAD TO HAVE THE DEVICES REMOVED APPROX FOUR MONTHS LATER, AND PUT BACK IN SEVEN MONTHS AFTER THAT. INCISION HAS NOT HEALED, BLOODY, DRAINAGE, WEEPY. SEIZURES STARTED AFTER SECOND SURGERY. HEAD FALLS TO THE RIGHT SIDE AND CANNOT MOVE. OTHER TIMES, THRASHES LIKE A BULL. HAS HAD A 101-102 TEMP/STAPH INFECTION SINCE HAVING THE DEVICE. INFECTION STARTED IMMEDIATELY AFTER THE IMPLANT WENT IN. PAIN GOT WORSE AFTER THE IMPLANT WENT IN. DID NOT FIX THE 13 MM OPENING, NOW A 7 MM OPENING. FOSSA WAS NEW, BUT THE MANDIBULAR DEVICE WAS NOT NEW AND WAS CHARGED FOR A NEW DEVICE.