FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI 11X200MM X 130
MDR report key: 1770211
·
Received July 21, 2010
Report
- Report Number
- 9610622-2010-00308
- Event Type
- Injury
- Date Received
- July 21, 2010
- Date of Event
- June 4, 2010
- Report Date
- July 2, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAME PT AS MDR 9610622-2010-00309.
Description of Event or Problem · 1
HEAD SURGEON REPORTED IN HIS LETTER THAT THE NAIL WAS IMPLANTED ON (B) (6) 2010. ON (B) (6) 2010, FIRST TIME RADIOLOGICALLY SHOWED VISIBLE BREAKAGE OF A SCREW. AFTER DETERIORATE OF SYMPTOMS, ON (B) (6) 2010 PROXIMAL BREAKAGE OF THE NAIL WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 11X200MM X 130 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K181961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |