IMP, TSV, 4.1, 1, MTX,MC,
Report
- Report Number
- 0002023141-2022-00508
- Event Type
- Malfunction
- Date Received
- February 24, 2022
- Date of Event
- January 7, 2022
- Report Date
- August 8, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024343993
- PMA / PMN Number
- K133339
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.
ONE (1) IMP, TSV, 4.1, 1, MTX,MC, (TSVM4H10) WAS RETURNED FOR INVESTIGATION . VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE DEVICE CAME OUTSIDE OF ORIGINAL PACKAGING. SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT VERIFIED THE IMPLANT, MOUNT AND SCREW COULD NOT BE DISENGAGE. A PRE-EXISTING CONDITION NOTED ON THE PER WAS UNKNOWN BONE DENSITY TYPE. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 30 (UNIVERSAL) AND WAS PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230041). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1230041) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. ADDITIONALLY, THE COOB COULD NOT BE VERIFIED WITH THE INFORMATION AVAILABLE.
IT WAS REPORTED THAT DR. INDICATED DEVICE MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH # 30.
IT WAS REPORTED THAT DR. INDICATED DEVICE MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH # 30.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 120722 | IMP, TSV, 4.1, 1, MTX,MC, | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVM4H10 | 1230041 | 00889024343993 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male |