FDA Adverse Event
Malfunction
Summary report: N
NAVIGATOR 12MM X 26MM X 4DEG
MDR report key: 2802455
·
Received October 18, 2012
Report
- Report Number
- 9617544-2012-00447
- Event Type
- Malfunction
- Date Received
- October 18, 2012
- Date of Event
- September 20, 2012
- Report Date
- September 20, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MAX
- PMA / PMN Number
- K100865
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 AN ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT ¿SURGEON ATTEMPTED TO IMPLANT 12X26X4 AVS NAVIGATOR INTO PT. AS HE IMPACTED THE IMPLANT BEFORE IT WAS IN THE PT DISC SPACE, THE IMPLANT FELL OFF OF THE INSERTER. UPON INSPECTION, THE ¿RAIL¿ ON THE PROXIMAL PORTION OF THE CAGE, WHERE THE INSERTER ATTACHES, BROKE OFF OF THE IMPLANT. IT WAS REMOVED, AND A NEW CAGE WAS INSERTED.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVIGATOR 12MM X 26MM X 4DEG | IMPLANT | MAX | STRYKER SPINE BORDEAUX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |