FDA Adverse Event
Malfunction
Summary report: N
CERVICAL SPACER, LORDOTIC, 13MM X 12MM X 7MM
MDR report key: 2443433
·
Received January 25, 2012
Report
- Report Number
- 2032593-2012-00004
- Event Type
- Malfunction
- Date Received
- January 25, 2012
- Date of Event
- December 29, 2011
- Report Date
- January 25, 2012
- Manufacturer
- SEASPINE, INC
- Product Code
- MAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE DEVICE CRACKED UPON INSERTION. A HAIRLINE FRACTURE WAS OBSERVED. THE DEVICE WAS REMOVED FROM THE SURGICAL SITE. THERE WAS NO HARM TO THE PT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERVICAL SPACER, LORDOTIC, 13MM X 12MM X 7MM | CAPISTRANO CERVICAL ALLOGRAFT | MAX | SEASPINE, INC | 101077485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |