FDA Adverse Event
Malfunction
Summary report: N
ZIMMER BIOMET
MDR report key: 6830526
·
Received August 30, 2017
Report
- Report Number
- MW5071839
- Event Type
- Malfunction
- Date Received
- August 30, 2017
- Date of Event
- August 25, 2017
- Report Date
- August 28, 2017
- Manufacturer
- BIOMET
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
BONE REDUCTION FORCEPS NOTED TO HAVE A BROKEN PIECE OF THE JAW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612902 | ZIMMER BIOMET | BONE REDUCTION FORCEPS | LXH | BIOMET | 9399 | 031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |