IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 8MM
Report
- Report Number
- 0002023141-2022-01340
- Event Type
- Malfunction
- Date Received
- June 1, 2022
- Date of Event
- February 14, 2022
- Report Date
- November 9, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020139
- PMA / PMN Number
- K061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.PMA/510K: K011028, K013227.
ONE (1) IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 8MM (TSVWH8) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE SCREW DID NOT DISENGAGE FROM THE MOUNT DURING EVALUATION. NON VERIFIABLE COOB, ITEM WAS RETURNED IN AN OPEN CONDITION, WITHOUT ORIGINAL PACKAGING. 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 IV). THE REPORTED DEVICE WAS LOCATED ON AN UNKNOWN TOOTH SITE (UNIVERSAL) 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 (1243145). 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 (1243145) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. THE COOB COULDN'T BE VERIFIED SINCE THE DEVICE WAS USED, AND THE CONDITIONS OF THE PRODUCT WHEN IT WAS RECEIVED ARE NON-VERIFIABLE.
THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H10: ADDED MANUFACTURER NARRATIVE.
IT WAS REPORTED THAT IMPLANT PLACED WITH 40 NCM TORQUE BUT WHEN THEY TRIED TO REMOVED THE MOUNT SCREW TO PLACED THE COVER, THE SCREW DID NOT COME OFF, DUE TO THE FORCE THE IMPLANT FELL OUT, AN ATTEMPT MAS MADE TO REPOSITION IT BUT WE WERE UNABLE TO REMOVED THE SCREW, A LARGE DIAMETER IMPLANT WAS REQUESTED AND PLACED WHICH WORKED WELL. DELAYED WAITING FOR THE NEW IMPLANT. PROCEDURE WAS COMPLETE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT AT THE TIME OF PLACING AN IMPLANT, IT WAS PLACED WELL, IT GAVE TORQUE AND STABILITY, BUT AT THE TIME OF REMOVING THE THROUGH SCREW THAT HOLDS THE PILLAR WITH WHICH THE IMPLANT COMES, IT WAS NOT REMOVED NO MATTER HOW LONG IT TOOK. I TRIED, SO MUCH THAT DUE TO THE FORCE OF TRYING TO REMOVE THE SCREW, THE IMPLANT ENDED UP COMING OUT OF ITS BED, WHICH FORCED ME TO DRILL AGAIN AND PLACE AN IMPLANT WITH A LARGER DIAMETER. AFTER VERIFYING THE IMPLANT THAT HAD BEEN PLACED OUTSIDE THE BED, NO MATTER HOW HARD I TRIED WITH THE SCREWDRIVERS, THE SCREW WAS NEVER REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1461046 | IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 8MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVWH8 | 1243145 | 00889024020139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female |