FDA Adverse Event
Injury
Summary report: N
PROXIMAL FEMORAL NAIL, ANTIROTATION, 10MM, LONG, LEFT
MDR report key: 2121382
·
Received June 7, 2011
Report
- Report Number
- 8030965-2011-00270
- Event Type
- Injury
- Date Received
- June 7, 2011
- Report Date
- May 16, 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
THIS INFORMATION WAS NOT PROVIDED. 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
PATIENT IMPLANTED WITH PROXIMAL FEMORAL NAIL, ANTIROTATION ON (B)(6) 2010. NAIL BROKE POSTOPERATIVELY AND WAS REMOVED AND REPLACED ON (B)(6) 2011. THE LOCKING BOLT WAS ALSO NOTED TO HAVE BROKEN POSTOPERATIVELY AND WAS REMOVED. THIS IS THE 1ST OF 2 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMAL FEMORAL NAIL, ANTIROTATION, 10MM, LONG, LEFT | PROXIMAL FEMORAL NAIL, ANTIROTATION | HSB | SYNTHES GMBH | 2610869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | BLADE| END CAP| LOCKING BOLT |