FDA Adverse Event
Other
Summary report: N
XIA DUAL STAPLE (LARGE CAUDAL)
MDR report key: 1426876
·
Received August 3, 2009
Report
- Report Number
- 9617544-2009-00311
- Event Type
- Other
- Date Received
- August 3, 2009
- Date of Event
- May 26, 2009
- Report Date
- May 26, 2009
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K06036
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE PRODUCT IDENTIFIER ETCHING ON THESE IMPLANTS HAVE "RS" INSTEAD OF "RL". CAT # IS CORRECT THOUGH. JUST NOTICED THIS IS IN A TRAY THAT IS RARELY USED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA DUAL STAPLE (LARGE CAUDAL) | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | HJ3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |