FDA Adverse Event
Malfunction
Summary report: N
CERTAIN® TITANIUM LARGE HEXED SCREW
MDR report key: 8305513
·
Received February 5, 2019
Report
- Report Number
- 0001038806-2019-00083
- Event Type
- Malfunction
- Date Received
- February 5, 2019
- Report Date
- February 21, 2019
- Manufacturer
- BIOMET 3I
- Product Code
- DZE
- PMA / PMN Number
- K972444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR INSPECTION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem · 0
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL 510K NUMBER: K072642. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ABUTMENT SCREW (ILRGHT) FRACTURED. THE FRACTURED PIECE OF SCREW COULD NOT BE REMOVED FROM THE IMPLANT. THE IMPLANT WAS NOT REMOVED AND THE DOCTOR CEMENTED A NEW PROSTHESIS. TOOTH LOCATION 30.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101448 | CERTAIN® TITANIUM LARGE HEXED SCREW | ABUTMENT SCREW | DZE | BIOMET 3I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |