FDA Adverse Event
Malfunction
Summary report: N
INSERTER
MDR report key: 2496136
·
Received March 8, 2012
Report
- Report Number
- 2032593-2012-00010
- Event Type
- Malfunction
- Date Received
- March 8, 2012
- Date of Event
- January 12, 2012
- Report Date
- March 8, 2012
- Manufacturer
- SEASPINE, INC
- Product Code
- FZX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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
ON (B)(6) 2012 THE REPORTER STATED, "WHILE REMOVING A TRAIL THE INSERTER PRONGS BROKE". THE SURGERY PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PT. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2012; IT WAS REPORTED THE DEVICE BROKE OVER THE OPEN INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSERTER | PACIFICA | FZX | SEASPINE, INC | AK132D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |