FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X380MM X 12
MDR report key: 2622488
·
Received June 14, 2012
Report
- Report Number
- 9610622-2012-00259
- Event Type
- Injury
- Date Received
- June 14, 2012
- Date of Event
- May 31, 2012
- Report Date
- May 31, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4) LAG SCREW, TI GAMMA3 10.5X90 MM, LOT# K494862, (B)(4), LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM LOT#K551495.
Description of Event or Problem · 1
THE SALES REP, REPORTED THAT THE NAIL FRACTURED AT THE POINT OF THE LAG SCREW HOLE SIX MONTHS FOLLOWING IMPLANTATION. THE SALES REP FURTHER REPORTED THAT THE PT WAS REVISED TO A COMPETITOR'S PLATE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X380MM X 12 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K113165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |