FDA Adverse Event
Other
Summary report: N
SCORPIO-FLEX PS X3 TIB INSERT
MDR report key: 1295803
·
Received January 20, 2009
Report
- Report Number
- 2249697-2009-00032
- Event Type
- Other
- Date Received
- January 20, 2009
- Date of Event
- December 26, 2008
- Report Date
- December 29, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- JWH
- PMA / PMN Number
- K051977
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE STERILE PACKAGE WHEN OPENED IN SURGERY. ANOTHER DEVICE WAS AVAILABLE AND WAS USED TO SUCCESSFULLY COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO-FLEX PS X3 TIB INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS | NA | 6PHMKD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |