IMP,TSV,4.1,10,MTX,MG
Report
- Report Number
- 0002023141-2022-01998
- Event Type
- Malfunction
- Date Received
- August 9, 2022
- Date of Event
- July 28, 2022
- Report Date
- February 2, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019829
- PMA / PMN Number
- K101977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.
ONE (1) IMP,TSV,4.1,10,MTX,MG (TSVT4B10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. FUNCTIONAL TESTING WITH AN IN-HOUSE REMOVAL TOOL TO RECREATE THE REPORTED EVENT; VERIFIED THE MOUNT WOULD NOT DISENGAGE FROM THE IMPLANT. MALFUNCTION CONFIRMED. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 34 (FDI) AND WAS USED, 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 (1250950). 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 (1250950) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) OR PRODUCT (TSVT4B10). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, AND FUNCTIONAL TESTING DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED. ADDITIONALLY, THE ALLEGED COOB COULD NOT BE VERIFIED, AS THE PACKAGING WAS NOT RETURNED, AND THE CIRCUMSTANCES OF DEVICE DELIVERY ARE UNKNOWN / NON-VERIFIABLE.
ONE (1) IMP,TSV,4.1,10,MTX,MG (TSVT4B10) WAS NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM AND LOT NUMBER ALONG WITH THE APPLICABLE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND RISK FILE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 34 (FDI) AND WAS USED, 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 (1250950). 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 (1250950) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. (B)(6) POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) OR PRODUCT (TSVT4B10). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. ADDITIONALLY, THE ALLEGED COOB COULD NOT BE VERIFIED, AS THE PRODUCT / PACKAGING WAS NOT RETURNED, AND THE CIRCUMSTANCES OF DEVICE DELIVERY ARE UNKNOWN / NON-VERIFIABLE.
IT WAS REPORTED THAT DURING PLACEMENT FIXTURE MOUNT CANNOT REMOVE FROM THE IMPLANT, SO IMPLANT WAS REMOVED. PROCEDURE COMPLETE WITH ANOTHER IMPLANT. TOOTH SITE # 21.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248316 | IMP,TSV,4.1,10,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVT4B10 | 1250950 | 00889024019829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male |