FDA Adverse Event
Malfunction
Summary report: N
POSTERIOR CERVICAL SYSTEM (ASCENT POCT)
MDR report key: 2491252
·
Received February 24, 2012
Report
- Report Number
- 3008524126-2012-00009
- Event Type
- Malfunction
- Date Received
- February 24, 2012
- Date of Event
- February 2, 2012
- Report Date
- February 24, 2012
- Manufacturer
- ORTHOFIX INC.
- Product Code
- KWP
- PMA / PMN Number
- K031097
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BASED ON THE INFO PROVIDED BOTH OF THE 65-3320 SCREWS BROKE AT LEVEL C2. THE SCREWS (3.5 MM X 20 MM MULTI-AXIAL SCREW) WERE REMOVED AND REPLACED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSTERIOR CERVICAL SYSTEM (ASCENT POCT) | 3.5MM X 20 MM MULTI-AXIAL SCREW | KWP | ORTHOFIX INC. | 65-3320 (X2) | P12 (X2) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other |