FDA Adverse Event
Injury
Summary report: N
1043534-2012-01149
MDR report key: 2755899
·
Received September 24, 2012
Report
- Report Number
- 1043534-2012-01149
- Event Type
- Injury
- Date Received
- September 24, 2012
- Report Date
- September 19, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K003016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND PHOTOGRAPHIC IMAGES WERE MADE. (B)(4).
Additional Manufacturer Narrative · 1
PER FDA, REOPENED FILE AS A REPORTABLE MALFUNCTION IN ORDER TO REPORT AS PART OF A RETROSPECTIVE REVIEW OF CERAMIC HEADS. THIS IS THE SAME EVENT AS 1043534-2012-01150, 01151.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO BROKEN NECK. HEALTHLY MALE. HE WAS ON A BUS, STOOD UP, BUS STOPPED, AND HE FELL. FRACTURE BELIEVED TO BE TRAUMATIC IN ORIGIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |