IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM
Report
- Report Number
- 0002023141-2023-00379
- Event Type
- Injury
- Date Received
- January 30, 2023
- Date of Event
- January 24, 2023
- Report Date
- June 5, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020061
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). K011028, K013227.
A IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM (TSVWB13) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE, HOWEVER NO DAMAGE IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THE RETURNED DEVICE WAS MEASURED AND VERIFIED TO MATCH DHR DRAWING. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICES LOCATION IS UNKNOWN AND WAS USED FOR APPROXIMATELY 4 DAYS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1252953). 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. STERILIZATION RECORD (OP160) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1252953) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. MAR 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 NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # UNKNOWN WAS REMOVED DUE TO PAIN. THE PATIENT COMPLAINED OF PAIN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
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 |
|---|---|---|---|---|---|---|---|
| 2006254 | IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVWB13 | 1252953 | 00889024020061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |