FDA Adverse Event
Malfunction
Summary report: N
VERTEX RECONSTRUCTION SYSTEM
MDR report key: 1820047
·
Received August 20, 2010
Report
- Report Number
- 1030489-2010-01085
- Event Type
- Malfunction
- Date Received
- August 20, 2010
- Date of Event
- July 6, 2010
- Report Date
- July 22, 2010
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- K042524
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CENTER NUT ON THE CROSSLINK BROKE DURING TIGHTENING. THE BROKEN DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTEX RECONSTRUCTION SYSTEM | CROSSLINK | KWP | WARSAW ORTHOPEDIC INC. | NA | W07L2714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |