FDA Adverse Event
Malfunction
Summary report: N
FPS LAPIDUS PLATE AND LOCKING SCREW
MDR report key: 2288304
·
Received October 4, 2011
Report
- Report Number
- 2027754-2011-00008
- Event Type
- Malfunction
- Date Received
- October 4, 2011
- Date of Event
- June 2, 2011
- Report Date
- October 4, 2011
- Manufacturer
- OSTEOMED
- Product Code
- JEY
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UNIT NOT RETURNED FOR EVAL. PHYSICIAN HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFO. MODEL # 322-2722.
Description of Event or Problem · 1
PLATE CRACKED AT LOCKING INTERFACE WITH SCREW AND PULLED LOOSE ON THE DORSAL/PROXIMAL HOLE; SCREW BROKE ON PLANTAR/PROXIMAL HOLE. PRODUCT WAS DISCARDED AND NOT RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FPS LAPIDUS PLATE AND LOCKING SCREW | BONE FIXATION PLATE/BONE FIXATION SCREW | JEY | OSTEOMED | 324-1290 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |