FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, STST, LEFT 11X400MM X 125
MDR report key: 2150632
·
Received June 23, 2011
Report
- Report Number
- 9610622-2011-00272
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 7, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE NURSE REPORTED TO SALES REP, THAT "THE NAIL WAS IMPLANTED IN 2009 AND THE PT UNDERWENT A REVISION SURGERY BECAUSE THE NAIL BROKE AT THE LEVEL OF THE LAG SCREW. THE PT WAS IMPLANTED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, STST, LEFT 11X400MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | TBD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |