FDA Adverse Event
Injury
Summary report: N
NI
MDR report key: 2032608
·
Received March 23, 2011
Report
- Report Number
- 8030965-2011-00088
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- December 13, 2010
- Report Date
- March 7, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN.
Description of Event or Problem · 1
DEVICE REPORT RECEIVED FROM HOSPITAL (B)(6) INDICATES A PATIENT WITH AN UNSTABLE PROXIMAL FEMUR FRACTURE WAS IMPLANTED WITH A NAIL. NAIL WAS NOTED AS BROKEN POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | NAIL | HSB | SYNTHES GMBH | NA | 2125399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | BLADE| SCREW |