FDA Adverse Event
Injury
Summary report: N
UNKNOWN_OSTEOSYNTHESIS_PRODUCT
MDR report key: 3200848
·
Received July 2, 2013
Report
- Report Number
- 0009610622-2013-00364
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 11, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-KIEL
- Product Code
- HSB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON 2011 (B)(6), GAMMA3 SURGERY WAS PERFORMED. ON 2013 (B)(6), A REVISION SURGERY WAS PERFORMED BECAUSE OF FEMORAL HEAD NECROSIS. DURING REVISION SURGERY THE SURGEON ATTEMPTED TO EXTRACT THE GAMMA NAIL FORCIBLY BY THA ANTERIOR APPROACH, IT TOOK ABOUT ONE HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301597 | UNKNOWN_OSTEOSYNTHESIS_PRODUCT | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS-KIEL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |