FDA Adverse Event
Malfunction
Summary report: N
MODULAR POLY DRIVER SHAFT
MDR report key: 2508495
·
Received March 26, 2012
Report
- Report Number
- 2032593-2012-00012
- Event Type
- Malfunction
- Date Received
- March 26, 2012
- Date of Event
- March 5, 2012
- Report Date
- March 26, 2012
- Manufacturer
- SEASPINE, INC.
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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 INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE, THE SCREWDRIVER TIP BROKE INSIDE THE SCREW HEAD AS THE SCREW WAS BEING PLACED IN THE PATIENT. FORCEPS WERE USED TO EXTRACT THE TIP. IT TOOK ONLY ABOUT HALF A MINUTE TO EXTRACT IT. X-RAYS WERE TAKEN AFTER THE SURGERY AND NO FOREIGN BODY WAS SEEN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODULAR POLY DRIVER SHAFT | MALIBU | NKB | SEASPINE, INC. | MW06636-B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |