FDA Adverse Event
Malfunction
Summary report: N
VERTEX RECONSTRUCTION SYSTEM
MDR report key: 1181751
·
Received September 18, 2008
Report
- Report Number
- 1030489-2008-00520
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 20, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- K042524
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION FOUND THAT THE EYELET POST WAS SHEARED DURING TIGHTENING DUE TO APPLICATION OF TORQUE THAT EXCEEDED POST LIMITS. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CENTER LOCKNUT OF THE CROSSLINK SHEARED OFF DURING TIGHTENING. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTEX RECONSTRUCTION SYSTEM | CROSSLINK | KWP | WARSAW ORTHOPEDIC INC. | NA | W08E3265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |