IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
Report
- Report Number
- 0002023141-2022-01674
- Event Type
- Malfunction
- Date Received
- June 30, 2022
- Date of Event
- May 3, 2022
- Report Date
- December 9, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020085
- PMA / PMN Number
- K061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). PMA/510K: K011028, K013227.
AN IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM (TSVWB8) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND A FRACTURE AT THE HEX OF A MOUNT. DRIVE FEATURE OF THE IMPLANT IS ALSO DAMAGED. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF USAGE OF THE DEVICE IS SAME DAY. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1231762). 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 WAS 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 (1231762) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. OCT POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES".
THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.
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. H3: CHANGED "NO" TO "YES". H10: ADDED MANUFACTURER NARRATIVE.
IT WAS REPORTED IMPLANT PLACEMENT #30 SITE. FLAPPED, DRAINED PER PROTOCOL, DENSE BONE DURING PLACEMENT, TRANSFER ABUTMENT FRACTURED AT CREST. REMOVED FRACTURED PORTION, REMOVED IMPLANT FOR FEAR THAT INTERNAL HEX WAS COMPROMISED. REPLACED WITH NEW 4.7X10. REMOVED IMPLANT AND REPLACED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE AREA INSIDE THE DRIVE WAS DAMAGED DURING REMOVAL. AS STATED IN THE REPORT, THE SMALL METAL CONNECTION AT THE BASE OF THE TRANSFER COPING SHEARED OFF DURING PLACEMENT (DESPITE USE OF DENSE BONE PROTOCOL) AND WAS WEDGED IN. IT COULD NOT BE REMOVED W/ TRADITIONAL INSTRUMENTS. IT WAS CUT USING A SMALL DRILL AND THE IMPLANT WAS REVERSE TORQUED OUT AND REPLACED W/ ANOTHER IMPLANT. I USED THIS PROTOCOL TO AVOID THE USE OF TREPHINE BURS DUE TO LIMITED AVAILABLE BONE. CUSTOMER REPORTED 54 YEAR OLD FEMALE FOR IMPLANT PLACEMENT #30 SITE. FLAPPED, DRAINED PER PROTOCOL, DENSE BONE DURING PLACEMENT, TRANSFER ABUTMENT FRACTURED AT CREST. REMOVED FRACTURED PORTION, REMOVED IMPLANT FOR FEAR THAT INTERNAL HEX WAS COMPROMISED. REPLACED WITH NEW 4.7X10. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVED IMPLANT AND REPLACED. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: NONE INDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2058941 | IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVWB8 | 1231762 | 00889024020085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female |