FDA Adverse Event
Injury
Summary report: N
5.5MM POLYAXIAL SCREW-OPEN 5.5 X 35
MDR report key: 1213721
·
Received October 28, 2008
Report
- Report Number
- 1649384-2008-00535
- Event Type
- Injury
- Date Received
- October 28, 2008
- Date of Event
- August 18, 2008
- Report Date
- October 28, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.
Description of Event or Problem · 1
IN 2008, THE DISTRIBUTOR REPORTED THAT DURING SURGERY, THE SURGEON ATTEMPTED TO IMPLANT A CLOSURE TOP WHEN IT CROSS THREADED. THE SURGEON THEN ATTEMPTED TO IMPLANT ANOTHER ONE, AND IT ALSO CROSS THREADED. THE SURGEON THEN EXPLANTED THE CLOSURE TOP AND SCREW AND IMPLANTED ANOTHER SCREW AND CLOSURE TOP. THERE WAS A MINIMAL SURGICAL DELAY OF 10 MINUTES TO REPLACE THE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.5MM POLYAXIAL SCREW-OPEN 5.5 X 35 | INCOMPASS | KWP | ABBOTT SPINE | 37PZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |