TMJ SYSTEM CROSS DRIVE FOSSA SCREW, 2.0 X 9 MM
Report
- Report Number
- 0001032347-2018-00701
- Event Type
- Injury
- Date Received
- October 25, 2018
- Report Date
- February 15, 2019
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- PMA / PMN Number
- K910038
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DATE OF EVENT: THE ORAL SURGEON'S OFFICE REPORTS THE PROCEDURE IS SCHEDULED FOR MARCH 4, 2019. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00694-2, 0001032347-2018-00695-2, 0001032347-2018-00696-2, 0001032347-2018-00697-2, 0001032347-2018-00698-2, 0001032347-2018-00699-2, 0001032347-2018-00700-2, 0001032347-2018-00702-2, AND 0001032347-2018-00703-2.
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. THE PATIENT REPORTED THAT THE RIGHT SIDE OF HER JAW WHERE SHE IS HAVING THE PAIN IS DISPLACED, HOWEVER, THIS COULD NOT BE CONFIRMED BASED ON THE MATERIALS PROVIDED. FOR AFOREMENTIONED REASONS, THE COMPLAINT CANNOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. IT WAS REPORTED THAT ONE OF THE RIGHT MANDIBLES WERE IMPLANTED IN THE PLACE OF THE LEFT MANDIBLE. THIS COULD BE A POTENTIAL CONTRIBUTING FACTOR TO THE PATIENTS CONDITION; HOWEVER, THIS COULD NOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT WARNS OF THE POTENTIAL FOR COMPLICATIONS. IT STATES IN THE SECTION TITLED ADVERSE EVENTS: ¿ FACIAL SWELLING AND/OR PAIN ¿ DISLOCATION THE IFU ALSO STATES IN THE SECTION TITLED PATIENT COUNSELING INFORMATION: DISCUSSION OF THE FOLLOWING POINTS IS RECOMMENDED PRIOR TO SURGERY. ¿ 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. 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 NUMBERS OF THE DEVICES INVOLVED IN THE EVENT IS UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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: 0001032347-2018-00694-1, 0001032347-2018-00695-1, 0001032347-2018-00696-1, 0001032347-2018-0067-1, 0001032347-2018-00698-1, 0001032347-2018-00699-1, 0001032347-2018-00700-1, 0001032347-2018-00702-1, AND 0001032347-2018-00703-1.
ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT REPORTED HER DENTIST DISLOCATED HER JOINT (SHE DIDN¿T SAY WHICH SIDE) AS HE WAS PULLING A TOOTH. NOW, SHE¿S BEEN HAVING MIGRAINES. THE PATIENT'S ORAL SURGEON'S OFFICE CONFIRMED THAT SHE IS SCHEDULED FOR AN EXPLORATION UNDER ANESTHESIA AND POSSIBLE REPLACEMENT OF BILATERAL JOINTS.
THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF THE INVESTIGATION.
(B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6545 LOT #: 934390, BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6550 LOT #: 980380, BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL CATALOG #: 24-6562 LOT #: 019050, BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL CATALOG #: 24-6563 LOT #: 853140, BIOMET MICROFIXATION "2.4MM" SYSTEM HT CROSS-DRIVE SCREW CATALOG #: 91-2708 LOT #: NI, BIOMET MICROFIXATION "2.4MM" SYSTEM HT CROSS-DRIVE SCREW CATALOG #: 91-2710 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW CATALOG #: 99-6577 LOT #: NI, BIOMET MICROFIXATION "2.7MM" SYSTEM EMERGENCY CROSS DRIVE SCREW CATALOG #: 99-9948 LOT #: NI, BIOMET MICROFIXATION "2.7MM" SYSTEM EMERGENCY CROSS DRIVE SCREW CATALOG #: 99-9950 LOT #: NI. THERAPY DATE: UNKNOWN. PATIENT CODE(S): NO CODE FOR OTALGIA (EAR PAIN). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT REMAINS 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: 0001032347-2018-00694, 0001032347-2018-00695, 0001032347-2018-00696, 0001032347-2018-00697, 0001032347-2018-00698, 0001032347-2018-00699, 0001032347-2018-00700, 0001032347-2018-00702, AND 0001032347-2018-00703.
THE PATIENT REPORTED "I HAVE PAIN ON THE RIGHT SIDE OF MY JAW AND BY MY RIGHT EAR WHEN I EAT. I HAVE HAD A LOT OF TEETH PULLED AND PRIOR JAW SURGERIES FOR A BROKEN JAW." UPON FOLLOW-UP, THE PATIENT REPORTED SHE HAD AN X-RAY DONE AT HER PRIMARY DOCTOR'S OFFICE EARLIER THIS WEEK AND SHE RECEIVED A CALL FROM HIM TODAY REPORTING THAT THE RIGHT SIDE OF HER JAW WHERE SHE IS HAVING THE PAIN IS DISPLACED. SHE STATED THAT DUE TO HER PREVIOUS JAW SURGERIES, THIS REQUIRED HER IMPLANTS TO BE "IMPLANTED HIGHER THAN NORMAL." SHE PLANS ON FOLLOWING UP WITH AN ORAL SURGEON TO SEE WHAT THEY RECOMMEND. AT THIS TIME THE PATIENT HAS NOT RECEIVED ANY ADDITIONAL TREATMENT AND NO REVISION IS PLANNED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 845907 | TMJ SYSTEM CROSS DRIVE FOSSA SCREW, 2.0 X 9 MM | BONE SCREW | JEY | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |