FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI 11X180MM X 130
MDR report key: 2032683
·
Received March 17, 2011
Report
- Report Number
- 9610622-2011-00119
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, "PT'S FAMILY REQUESTED THE TITANIUM NAIL BE REMOVED AND REPLACED WITH A STAINLESS STEEL VERSION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 11X180MM X 130 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K141051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |