FDA Adverse Event
Injury
Summary report: N
XIA 3 TITANIUM ROD DIAM 6MM ALLOY L 480MM
MDR report key: 2081361
·
Received April 29, 2011
Report
- Report Number
- 9617544-2011-00147
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- March 31, 2011
- Report Date
- March 31, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K071373
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PT WAS BROUGHT BACK TO THE OPERATING ROOM ONE YEAR POST-OP TO REPLACE BROKEN RODS AND SCREWS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM ROD DIAM 6MM ALLOY L 480MM | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |