FDA Adverse Event
Injury
Summary report: N
XIA II VITALIUM ROD 6.0 MM X 600 MM
MDR report key: 2051067
·
Received April 5, 2011
Report
- Report Number
- 9617544-2011-00128
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 25, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K060979
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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 CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
A PT UNDERWENT A SURGICAL PROCEDURE OF ARTHRODESIS AND DECOMPRESSION ON (B)(6) 2009 DUE TO DEGENERATIVE DISCOPATHY OF L5-S1. ON (B)(6) 2011, THE PT UNDERWENT AN UNANTICIPATED REVISION SURGERY DUE TO THE BREAKAGE OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA II VITALIUM ROD 6.0 MM X 600 MM | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | ZLC L040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |