FDA Adverse Event
Injury
Summary report: N
GAMMA NAIL
MDR report key: 2202584
·
Received August 8, 2011
Report
- Report Number
- 9610622-2011-00346
- Event Type
- Injury
- Date Received
- August 8, 2011
- Date of Event
- October 12, 2009
- Report Date
- July 18, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
PT CONTACTED STRYKER (B)(4) OVER THE PHONE ON THE (B)(6) 2011. SHE HAD A GAMMA NAIL IMPLANTED INTO HER FEMUR ON THE (B)(6) IN 2009 AND THAT THE NAIL FRACTURED ON THE (B)(6) 2010, WHILE SHE WAS WALKING ON CRUTCHES. SHE WAS ASKING US IF THERE HAD BEEN ANY RECALLS ON GAMMA NAILS AND WANTED FURTHER INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GAMMA NAIL | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |