FDA Adverse Event
Malfunction
Summary report: N
XIA ROD DIA. 6 X 480
MDR report key: 2145979
·
Received June 2, 2011
Report
- Report Number
- 9617544-2011-00196
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 10, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWQ
- PMA / PMN Number
- K984251
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L PMA/510(K)# K060361. ADDITIONAL 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 THE CAGE (NOT STRYKER PRODUCT) SANK AND 'XIA ROD DIA. 6 X 480' WAS BROKEN. THE ROD WAS IMPLANTED ON (B)(6) 2008. ON (B)(6) 2011, THE ROD WAS EXCHANGED WITH NEW ROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA ROD DIA. 6 X 480 | IMPLANT | KWQ | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| O| R |