FDA Adverse Event
Injury
Summary report: N
FEMORAL NAIL, LEFT 10X380 MM
MDR report key: 2188750
·
Received July 22, 2011
Report
- Report Number
- 9610622-2011-00327
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 1, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032898
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETAINED BY THE PT. ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, "PT ORIGINALLY HAD A FEMUR FRACTURE ON (B)(6) 2011 THAT WAS TREATED WITH A GTN FEMORAL NAIL. GTN NAIL BROKE ON (B)(6) 2011. PT HAD REVISION SURGERY ON (B)(6) 2011 WHERE GTN WAS REMOVED AND SURGEON WENT IN WITH A GAMMA 3."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL NAIL, LEFT 10X380 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K295408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |