FDA Adverse Event
Injury
Summary report: N
5X10 ANGLED LOCK FRAC PLATE,LT
MDR report key: 3172633
·
Received June 17, 2013
Report
- Report Number
- 0001032347-2013-00201
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- PMA / PMN Number
- PK980512
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
A REVISION SURGERY WAS REPORTED DUE TO A BROKEN PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272793 | 5X10 ANGLED LOCK FRAC PLATE,LT | MANDIBULAR PLATE | JEY | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |