FDA Adverse Event
Injury
Summary report: N
PROXIMAL FEMORAL NAIL
MDR report key: 2132559
·
Received June 10, 2011
Report
- Report Number
- 8030965-2011-00275
- Event Type
- Injury
- Date Received
- June 10, 2011
- Report Date
- May 18, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HSB
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PART NUMBER ASSOCIATED WITH DEVICE ONLY SOLD IN (B)(6). INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
PT IMPLANTED WITH A PROXIMAL FEMORAL NAIL ON (B)(6) 2008 FOR TREATMENT OF TROCHANTERIC FRACTURE. NAIL BROKE POSTOP. SIX WEEKS POSTOP, PT WAS FREE OF WEIGHT BEARING. ON (B)(6) 2008, PARTIAL WEIGHT BEARING WAS PERMITTED. ON (B)(6) 2008, PT FELT PAIN AND IMPLANT WAS REMOVED ON (B)(6) 2008. X-RAYS DID NOT REVEAL BROKEN NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMAL FEMORAL NAIL | PROXIMAL FEMORAL NAIL | HSB | SYNTHES GMBH | 2223971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |