FDA Adverse Event
Injury
Summary report: N
INCOMPASS
MDR report key: 858279
·
Received June 1, 2007
Report
- Report Number
- 1649384-2007-00061
- Event Type
- Injury
- Date Received
- June 1, 2007
- Date of Event
- May 1, 2007
- Report Date
- June 1, 2007
- Manufacturer
- ABBOTT SPINE, INC.
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT RETURN HAS BEEN REQUESTED. INVESTIGATION IS PENDING RECEIPT OF PRODUCT.
Description of Event or Problem · 1
IN 2007, DURING A THORACOLUMBAR SURGERY, THE SURGEON WAS IMPLANTING THE CLOSURE TOP TO LOCK THE CONSTRUCT AND THE THREADS OF THE CLOSURE TOP WERE DAMAGED. THE SURGEON REMOVED THE CLOSURE TOP AND A DAMAGED SCREW, SUBSEQUENTLY COMPLETING THE CASE AS INTENDED. THERE WAS A SURGICAL DELAY OF 10 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCOMPASS | INCOMPASS 5.5MM TI CLOSURE TOP (W/ THRE | KWP | ABBOTT SPINE, INC. | NA | 43 NP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention | 6.5MM X 40MM POLYAXIAL SCREW- OPEN| 5.5MM TI |