FDA Adverse Event
Malfunction
Summary report: N
CERTAIN® TITANIUM LARGE HEXED SCREW
MDR report key: 9713548
·
Received February 14, 2020
Report
- Report Number
- 0001038806-2020-00360
- Event Type
- Malfunction
- Date Received
- February 14, 2020
- Date of Event
- September 26, 2018
- Report Date
- April 27, 2020
- 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
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE COMPLETED. 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
ZIMMER BIOMET (B)(4). PATIENT WEIGHT NOT PROVIDED/UNKNOWN. DEVICE LOT NUMBER NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K072642. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176405 | CERTAIN® TITANIUM LARGE HEXED SCREW | ABUTMENT SCREW | DZE | BIOMET 3I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |