FDA Adverse Event
Injury
Summary report: N
U-BLADE SET, TI GAMMA3 Ø10.5X80MM
MDR report key: 4123969
·
Received September 27, 2014
Report
- Report Number
- 0009610622-2014-00517
- Event Type
- Injury
- Date Received
- September 27, 2014
- Date of Event
- August 28, 2013
- Report Date
- September 8, 2014
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- PMA / PMN Number
- K043431
- Adverse Event
- Yes
- Product Problem
- 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 PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
ON (B)(6) 2012, THE PATIENT UNDERWENT SURGERY WITH GAMMA3 NAIL. (B)(6) 2013, THE SURGEON FOUND THAT THE LAG SCREW HAD CUT OUT OF THE FEMORAL HEAD. THE SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2013 AND IMPLANTED A BHA. THIS CASE WAS ACQUIRED FROM THE CENTRAL JAPAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603746 | U-BLADE SET, TI GAMMA3 Ø10.5X80MM | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER TRAUMA KIEL | K843733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Required Intervention |