FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER LONG GAMMA NAIL LOT#K0B4A9D
MDR report key: 5868285
·
Received August 11, 2016
Report
- Report Number
- 0009610622-2016-00401
- Event Type
- Injury
- Date Received
- August 11, 2016
- Date of Event
- June 14, 2016
- Report Date
- July 13, 2016
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE FDA VIA REPORT MW 5063295: PATIENT HAD INTERLOCKING INTRAMEDULLARY LONG GAMMA NAIL FOR A SUBTROCHANTERIC FRACTURE ON 2016. DEVELOPED ONSET OF PAIN AFTER RIGOROUS PHYSICAL AND OCCUPATIONAL THERAPY SESSION. FOLLOW UP ED SHOWED TIP OF NAIL BEDDING AND FRACTURE TO FALL IN VARUS. ON 2016 HAD TO HAVE LONG GAMMA NAIL REMOVED AND REPLACED DUE TO BIOMECHANICAL FAILURE. REQUIRED AN ADDITIONAL SURGERY/HOSPITALIZATION A LITTLE MORE THAN 2 MONTHS STATUS POST LEFT SUBTROCHANTERIC FRACTURE WITH LONG GAMMA NAIL REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 520329 | UNKNOWN STRYKER LONG GAMMA NAIL LOT#K0B4A9D | IMPLANT | HSB | STRYKER TRAUMA KIEL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |