FDA Adverse Event
Malfunction
Summary report: N
2.0/1.0 6 HOLE MEDIUM COMPRESSION PLATE
MDR report key: 1739847
·
Received June 29, 2010
Report
- Report Number
- 1032347-2010-00111
- Event Type
- Malfunction
- Date Received
- June 29, 2010
- Date of Event
- January 18, 2010
- Report Date
- June 10, 2010
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- PMA / PMN Number
- K854886
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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
IT WAS REPORTED THE PATIENT HAD PLATES AND SCREWS IMPLANTED IN THE MANDIBLE ON (B)(6) 2009. X-RAYS ON (B)(6) 2010 SHOWED ALL WAS OK; X-RAY ON (B)(6) 2010 SHOWED THE PLATE WAS BROKEN. A REVISION SURGERY WAS PERFORMED WHERE THE PLATES AND SCREWS WERE REMOVED AND REPLACED WITH A NEW PLATE AND SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.0/1.0 6 HOLE MEDIUM COMPRESSION PLATE | BONE PLATE | JEY | BIOMET MICROFIXATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization |