FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI 10X170 MM X 125
MDR report key: 2012878
·
Received March 1, 2011
Report
- Report Number
- 9610622-2011-00095
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- January 6, 2011
- Report Date
- February 15, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
ON 2008 (B)(6), THE PATIENT UNDERWENT SURGERY WITH A G3 TROCHANTERIC NAIL. ON (B)(6) 2010, THE PATIENT FELL AND THE DISTAL RADIUS WAS FRACTURED. IN (B)(6) 2010, THE PATIENT FELT PAIN IN HIP. THE SURGEON WAS MONITORING THE PATIENT. ON 2011 (B)(6), THE SURGEON CONFIRMED BY X-RAY THAT THE LAG SCREW HOLE ON THE NAIL WAS BROKEN. ON 2011 (B)(6), THE PATIENT WAS REVISED WITH A G3 LONG NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 10X170 MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K706155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |