FDA Adverse Event
Other
Summary report: N
50MM LEFT SIDE MANDIBULAR
MDR report key: 1053564
·
Received May 29, 2008
Report
- Report Number
- 1032347-2008-00016
- Event Type
- Other
- Date Received
- May 29, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 30, 2008
- Manufacturer
- BIOMET MICROFIXATION, INC.
- Product Code
- LZD
- PMA / PMN Number
- P020016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
PT HAD 50MM LEFT SIDE MANDIBULAR IMPLANTED ON THE RIGHT SIDE IN EARLY 2008. DUE TO RESIDUAL MALOCCLUSION, THE IMPLANT WAS REMOVED THREE MONTHS LATER, AND REPLACED WITH A 50MM RIGHT SIDE OFFSET MANDIBULAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 50MM LEFT SIDE MANDIBULAR | TMJ | LZD | BIOMET MICROFIXATION, INC. | 187990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | SCREWS WOULD HAVE BEEN USED TO FIXATE IMPLANT| UNK WHICH SIZE OR HOW MANY WERE USED |