"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
Report
- Report Number
- 0001032347-2018-00328
- Event Type
- Injury
- Date Received
- June 1, 2018
- Report Date
- October 31, 2018
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HWC
- PMA / PMN Number
- PK001238
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. FOR AFOREMENTIONED REASONS, AND DUE TO THE FACT THAT PAIN IS A RELATIVE CONDITION, THE COMPLAINT CANNOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT WARNS OF THE POTENTIAL FOR COMPLICATIONS. IT STATES IN THE SECTION TITLED ADVERSE EVENTS: INFECTION (SYSTEMIC OR SUPERFICIAL). FACIAL SWELLING AND/OR PAIN. THE IFU ALSO STATES IN THE SECTION TITLED PATIENT COUNSELING INFORMATION: DISCUSSION OF THE FOLLOWING POINTS IS RECOMMENDED PRIOR TO SURGERY. THE IMPORTANCE OF PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE UNUSUAL SWELLING IN THE AREA OF THE IMPLANT. THE RISKS ASSOCIATED WITH A TOTAL TMJ SYSTEM (SEE WARNINGS AND ADVERSE EVENTS). POST-OPERATIVE PAIN RELIEF AND RETURN OF FUNCTION VARIES FROM PATIENT TO PATIENT. THE MANUFACTURING HISTORY WAS REVIEWED FOR THE TMJ COMPONENTS AND NO DISCREPANCIES WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE LOT NUMBER OF THE DEVICES INVOLVED IN THE EVENT IS UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00326-1, 0001032347-2018-00327-1, 0001032347-2018-00329-1, 0001032347-2018-00330-1.
THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF THE INVESTIGATION.
(B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL CATALOG #: 24-6563 LOT #: 328410, BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6556 LOT #: 209270, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW CATALOG #: 99-6579 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW CATALOG #: 99-6581 LOT #: NI. THERAPY DATE: UNKNOWN. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE DEVICES REMAIN IMPLANTED. 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: 0001032347-2018-00326, 0001032347-2018-00327, 0001032347-2018-00329, AND 0001032347-2018-00330.
IT WAS REPORTED BY THE PATIENT SHE "STARTED HER RADIATION TREATMENT FOR HER ORAL CANCER WITHIN THE LAST SIX MONTHS. SHE WAS TOLD THAT THE IMPLANTS DEFLECTED THE RADIATION. SHE SAYS THIS CAUSED OTHER TEETH TO BE IMPACTED BY THE RADIATION EVEN THOUGH THEY WERE NOT EXPECTED TO BE IMPACTED; THESE TEETH ARE BREAKING APART. SHE SAYS SHE CANNOT AFFORD A REVISION AT THIS TIME BUT IS RECEIVING PRESCRIPTION ANTIBIOTICS FOR THE INFECTION. HER SYMPTOMS INCLUDE PAIN, SWELLING, AND PUSSING AROUND THE JOINT." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405793 | "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW | BONE SCREW | HWC | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |