FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X420MM X 125°
MDR report key: 2990067
·
Received March 5, 2013
Report
- Report Number
- 0009610622-2013-00095
- Event Type
- Injury
- Date Received
- March 5, 2013
- Date of Event
- December 11, 2012
- Report Date
- February 8, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED VIA USER FACILITY REPORT (B)(4), THAT PATIENT HAD FALLEN AND BROKE THE GAMMA NAIL THAT WAS ORIGINALLY PLACED BY THE SURGEON APPROXIMATELY SIX MONTHS AGO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93968 | LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X420MM X 125° | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS-KIEL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |