FDA Adverse Event
Malfunction
Summary report: N
VERTEX RECONSTRUCTION SYSTEM
MDR report key: 1021055
·
Received March 28, 2008
Report
- Report Number
- 1030489-2008-00166
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- February 29, 2008
- Report Date
- February 29, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- K042524
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVAL. VISUAL EXAMINATION CONFIRMED THE EYEBOLT POST IS SHEARED AT THE BASE. CAUSE OF SHEAR IS LIKELY DUE TO APPLICATION OF TORQUE THAT EXCEEDED POST CAPABILITY. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CROSSLINK CENTER LOCKNUT WAS BROKEN OFF DURING TIGHTENING AS THE SURGEON WAS TRYING TO IMPLANT THE DEVICE. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTEX RECONSTRUCTION SYSTEM | CROSSLINK | KWP | WARSAW ORTHOPEDIC INC. | NA | W07L0049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |