TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL
Report
- Report Number
- 0001032347-2019-00285
- Event Type
- Injury
- Date Received
- May 20, 2019
- Report Date
- October 1, 2019
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- LZD
- UDI-DI
- 00841036036584
- PMA / PMN Number
- P020016
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- DENTIST
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. BECAUSE THERE WAS A REVISION SURGERY REPORTED, THE COMPLAINT IS CONSIDERED TO BE CONFIRMED. THE COMPLAINT WAS OPENED BECAUSE THE PATIENT REPORTED: "THEY WENT TOO FAR WITH ONE OF THE SCREWS AND IT IS HITTING MY BRAIN." SHE STATED THE SCREW IS ACTUALLY TICKLING HER BRAIN AND CAUSING HEADACHES, DOUBLE VISION, DEJA VU, SEIZURES, NERVE PAIN, AND SHE SMELLS WEIRD THINGS. NO PRODUCT WAS RETURNED, THEREFORE, NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. IT WAS REPORTED THAT ONE OF THE SCREWS WAS INSERTED TOO FAR, WHICH LED TO THE SYMPTOMS DESCRIBED ABOVE. IT WAS ALSO REPORTED THAT THE SCREW WAS REMOVED IN JUNE 2019 AND REPLACED WITH ANOTHER SCREW. THE DHR FOR THE FOSSA COMPONENT WAS REVIEWED, ONE NONCONFORMANCE WAS FOUND. NC9123 WAS OPENED AS A BATCH DEVIATION, HOWEVER, IT WAS DETERMINED THAT THE PRODUCT WAS NOT AFFECTED BY THE ISSUE AND ARE ACCEPTABLE TO CONTINUE PROCESSING. FOR ALL NON-CUSTOM TMJ FOSSA IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE SCREW BEING TOO LONG OR IMPROPER PLACEMENT (INCLUDING THIS COMPLAINT), THERE IS A COMPLAINT RATE OF 0.19%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE AFMEA. DUE TO THE LACK OF X-RAYS, SCANS, PHYSICIAN'S REPORTS, AND DETAILS REGARDING THE EXPLANTED SCREW AND REPLACEMENT SCREW, THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE ORIGINALLY IMPLANTED SCREW WAS NOT SIZED PROPERLY. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION 45 MM LFT NARROW TI MAND, CATALOG #: 01-6546TI, LOT #: 855250B; UNKNOWN. BIOMET MICROFIXATION SCREWS (POTENTIAL), CATALOG #: 91-2710, 99-6577, AND 99-6579. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00286.
IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING SEVERAL NEUROLOGICAL SYMPTOMS SINCE HER TMJ REPLACEMENT SURGERY APPROXIMATELY FOUR MONTHS AGO. THE PATIENT REPORTS THAT ONE OF THE SCREWS WAS PLACED TOO FAR AND IT IS HITTING HER BRAIN WITH SYMPTOMS INCLUDING: SMELLING WEIRD THINGS, HAVING DEJA VU, TROUBLE REMEMBERING WHAT SHE IS GOING TO SAY, HEADACHES, DOUBLE VISION IN THE LEFT EYE AND IRRITABILITY AND SEIZURES. THE PATIENT WAS REFERRED TO A NEUROLOGIST AFTER MENTIONING THE HEADACHES AND REPORTS THE NEUROLOGIST SUGGESTED REMOVING THE SCREW AND REPLACING IT WITH A SMALLER ONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416454 | TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL | JOINT, TEMPOROMANDIBULAR, IMPLANT | LZD | BIOMET MICROFIXATION | N/A | 822060A | 00841036036584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |