FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, STST, RIGHT 11X360MM X 125
MDR report key: 1701658
·
Received May 25, 2010
Report
- Report Number
- 9610622-2010-00219
- Event Type
- Injury
- Date Received
- May 25, 2010
- Date of Event
- May 10, 2010
- Report Date
- May 10, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K043431
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ASSOCIATED DEVICE IN THIS EVENT IS CATALOG NO. 4060-0095S LOT NO. K261752 LAG SCREW, STST 10.5X95MM. IT IS NOT KNOWN AT THIS TIME WHICH DEVICE IF ANY CAUSED THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SALES REP, THAT AT (B) (6) THE SURGEON COULDN'T INSERT THE LAG SCREW MENTIONED BELOW INSIDE THE NAIL AS THE HOLE WAS TOO TIGHT. IT WAS FURTHER REPORTED THAT THE SURGEON EXTRACTED THE LONG NAIL AND IMPLANTED A NAIL 4225-0380S INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, STST, RIGHT 11X360MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K230189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |