FDA Adverse Event
Injury
Summary report: N
LEFT STANDARD MANDIBULAR TMJ COMPONENT
MDR report key: 1982401
·
Received February 9, 2011
Report
- Report Number
- 1032347-2011-00014
- Event Type
- Injury
- Date Received
- February 9, 2011
- Date of Event
- November 1, 2010
- Report Date
- December 8, 2010
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- LZD
- PMA / PMN Number
- P020016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXPLANTED DEVICE WAS REPLACED WITH ANOTHER MANDIBULAR DEVICE DURING THE SAME REVISION SURGERY. 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 THE LEFT MANDIBULAR TMJ COMPONENT EXPLANTED ON (B)(6) 2010 AS THE SCREWS WERE LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEFT STANDARD MANDIBULAR TMJ COMPONENT | TMJ | LZD | BIOMET MICROFIXATION | 123450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |