FDA Adverse Event
Malfunction
Summary report: N
LATERAL IMPLANT WIDE LORDOTIC 14MM X 23MM X 50MM X
MDR report key: 3958791
·
Received June 26, 2014
Report
- Report Number
- 2032593-2014-00029
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- June 20, 2013
- Report Date
- June 2, 2014
- Manufacturer
- SEASPINE, INC.
- Product Code
- MAX
- PMA / PMN Number
- K112986
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
IT WAS REPORTED: DURING IMPLANTATION THE IMPLANT FRACTURED NEAR WHERE THE INSERTER ATTACHES. THE IMPLANT WAS SUCCESSFULLY REMOVED, AND A NEW CAGE WAS IMPLANTED. A SPARE DEVICE WAS AVAILABLE WHICH WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED BY TEN MINUTES. A CONFIRMATION X-RAY WAS PERFORMED. THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373731 | LATERAL IMPLANT WIDE LORDOTIC 14MM X 23MM X 50MM X | VU APOD-L | MAX | SEASPINE, INC. | BN019716B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |