FDA Adverse Event
Injury
Summary report: N
U-BLADE SET, TI 10.5X95MM
MDR report key: 2315743
·
Received October 24, 2011
Report
- Report Number
- 9610622-2011-00529
- Event Type
- Injury
- Date Received
- October 24, 2011
- Date of Event
- August 19, 2011
- Report Date
- October 3, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K043431
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. OTHER DEVICES ASSOCIATED WITH THIS DEVICE ARE: 3125-0170S, K108355, TROCHANTERIC NAIL KIT, TI 10X170MM X 125; 1896-5040S, K390715, LOCKING SCREW, FULLY THREADED 5X40 MM.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT UNDERWENT THE SURGERY WITH THE G3 NAIL. WHEN THE SURGEON CONFIRMED THE X-RAY BECAUSE 10 DAYS AFTER THE PT FELL, THE GAP OCCURRED IN THE FRACTURE PART. THE SURGEON REMOVED THE IMPLANTS AND THE PT UNDERWENT THE REVISION SURGERY. THE SURGEON DOUBTS WHETHER SET SCREW WAS FUNCTIONING NORMALLY. THE SURGEON REQUESTED THE INVESTIGATION OF THE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U-BLADE SET, TI 10.5X95MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K164020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |