CERTAIN® GOLD-TITE® HEXED SCREW
Report
- Report Number
- 0001038806-2022-01315
- Event Type
- Malfunction
- Date Received
- August 25, 2022
- Report Date
- January 19, 2023
- Manufacturer
- BIOMET 3I
- Product Code
- NHA
- PMA / PMN Number
- K072642
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMERBIOMET COMPLAINT NUMBER (B)(4).
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. SINCE PRODUCTS HAVE NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PRODUCT EXPERIENCE REPORT (PER). X-RAY OR PICTURE WAS NOT PROVIDED. A DEVICE HISTORY RECORD (DHR)REVIEW WAS PERFORMED AND NO RELATED DEVIATIONS OR NON-CONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO RELATED COMPLAINTS FOR THIS PRODUCT LOT. A DEVICE HISTORY RECORD (DHR) REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBERS ASSOCIATED WITH THE REPORTED PRODUCT ARE NOT AVAILABLE. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. COMPLAINANT REPORTED THAT THE SCREW LOOSENED IN THE PATIENT'S MOUTH. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.
IT WAS REPORTED THAT THE SCREW LOOSENED IN THE PATIENT'S MOUTH. THE SCREW WAS RETIGHTENED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2375075 | CERTAIN® GOLD-TITE® HEXED SCREW | ABUTMENT SCREW | NHA | BIOMET 3I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |