CERTAIN¿ GOLD-TITE¿ LARGE HEXED SCREW
Report
- Report Number
- 0001038806-2022-01647
- Event Type
- Malfunction
- Date Received
- October 29, 2022
- Report Date
- March 13, 2023
- Manufacturer
- BIOMET 3I
- Product Code
- DZE
- UDI-DI
- 00844868006121
- PMA / PMN Number
- K972444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. DATE OF EVENT: UNKNOWN / NOT PROVIDED. PMA/510K: K072642.
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 "YES" TO "NO" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE NOT RETURNED.
TWO CERTAIN® GOLDTITE® LARGE HEXED SCREW, ILRGHG WERE NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL INSPECTION COULD NOT BE PERFORMED. THE UNKNOWN ZIMMER IMPLANT REMAINS IMPLANTED AND THEREFORE, COULD NOT BE VISUALLY INSPECTED. THIS INVESTIGATION WILL BE OF THE AVAILABLE INFORMATION OF THE IFUS AND RISK MANAGEMENT FILES. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED AND NO PER FORM WAS PROVIDED. BONE DENSITY TYPE IS UNKNOWN. THE REPORTED DEVICE WERE LOCATED ON AN TOOTH SITES #11 & 13 AND WAS USED FOR AN UNKNOWN AMOUNT OF TIME. PICTURE/X-RAYS: PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241287 & 1241003). 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. A COMPLAINT HISTORY REVIEW WAS PERFORMED BY SUBJECT LOT NUMBERS (1241287 & 1241003) FOR SIMILAR EVENTS, GOING BACK 12 MONTHS FROM NOTIFICATION DATE, AND THERE ARE NO EXISTING NON-CONFORMANCE'S/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FRACTURE SCREW) AND DEVICE (ILRGHG X 2). BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AS THE EXACT DETAILS OF THE REPORTED EVENT WAS NON-VERIFIABLE AND THE PRODUCT WAS NOT RETURNED. 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 "YES" TO "NO"; H6: ENTERED EVALUATION CODES; H10: ADDED MANUFACTURER NARRATIVE.
IT WAS REPORTED THAT SCREW BROKE IN TOOTH SITE (PART OF A BRIDGE). TOOTH LOCATION: 14. BROKEN SCREW IS STILL IN THE PATIENT'S MOUTH AND WILL BE REMOVED IN THE NEXT FEW DAYS. IMPLANT REMAINS IMPLANTED.
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 |
|---|---|---|---|---|---|---|---|
| 2312834 | CERTAIN¿ GOLD-TITE¿ LARGE HEXED SCREW | DENTAL SCREW | DZE | BIOMET 3I | ILRGHG | 1241003 | 00844868006121 |
| 2912219 | CERTAIN¿ GOLD-TITE¿ LARGE HEXED SCREW | DENTAL SCREW | DZE | BIOMET 3I | ILRGHG | 1241003 | 00844868006121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female |