FDA Adverse Event
Malfunction
Summary report: N
5.5MM POLYAXIAL SCREW-OPEN 7.5 X 40
MDR report key: 1193193
·
Received October 7, 2008
Report
- Report Number
- 1649384-2008-00502
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 10, 2008
- Report Date
- October 7, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT DID NOT OCCUR IN SURGERY. EVALUATION IS PENDING.
Description of Event or Problem · 1
ON 10 SEP 2008, THE OFFICE MANAGER REPORTED THAT DURING A HOSPITAL INVENTORY AUDIT, IT WAS IDENTIFIED THAT THE SCREW WAS DISASSEMBLED IN THREE PIECES. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.5MM POLYAXIAL SCREW-OPEN 7.5 X 40 | INCOMPASS | KWQ | ABBOTT SPINE | 41CK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |