FDA Adverse Event
Injury
Summary report: N
LOCKING MANDIBULAR RECONSTRUCTION PLATE
MDR report key: 3003842
·
Received March 12, 2013
Report
- Report Number
- 9610905-2013-00007
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- March 14, 2013
- Report Date
- March 6, 2013
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH CO. KG
- Product Code
- MQN
- PMA / PMN Number
- K032442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
MANDIBULAR PLATE WAS USED TO BRIDGE A VOID. PLATE WAS FOUND TO BE FRACTURED. SURGEON IS REPLACING IT WITH A THICKER 3MM PROFILE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102926 | LOCKING MANDIBULAR RECONSTRUCTION PLATE | MQN | KARL LEIBINGER MEDIZINTECHNIK GMBH CO. KG | 50-757-26-09 | 31922129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |