FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°
MDR report key: 4123977
·
Received September 27, 2014
Report
- Report Number
- 0009610622-2014-00508
- Event Type
- Injury
- Date Received
- September 27, 2014
- Date of Event
- May 18, 2010
- Report Date
- September 10, 2014
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
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
FRACTURE AROUND GAMMA NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603917 | TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130° | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER TRAUMA KIEL | K740580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |