FDA Adverse Event
Malfunction
Summary report: N
NAVIGATOR 11MM X 31MM X 0DEG. SPACER
MDR report key: 2082833
·
Received April 29, 2011
Report
- Report Number
- 9617544-2011-00138
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 22, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MAX
- PMA / PMN Number
- K100865
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- 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
IT WAS REPORTED THAT, "AVS NAVIGATOR CAGE WAS INSERTED, WHILE IMPACTING THE BACK RAIL BROKE OFF OF CAGE AWAY FORM INSERTER. RAIL WAS STUCK IN INSERTER AND SURGEON REMOVED CAGE WITH OTHER INSTRUMENTS. HE REPLACED IT WITH AN AVS TL CAGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVIGATOR 11MM X 31MM X 0DEG. SPACER | IMPLANT | MAX | STRYKER SPINE BORDEAUX | NA | 10A003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |