BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1834483 · Received September 10, 2010

    Report

    Report Number
    1030489-2010-01166
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 19, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): MICROSCOPIC EXAMINATION OF ALL FRACTURE SURFACES REVEALED A FAIRLY BRITTLE FRACTURE WITH RIVER LINES AND NO INDICATION OF FATIGUE, INDICATIVE OF OVERLOAD. PER EVENT INFO, FAILURE DURING INTRAOPERATIVE TIGHTENING SUGGESTS OVER-TIGHTENING AS POTENTIAL MECHANISM OF FAILURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRAL LOCK NUT BROKE WITH VERY LITTLE PRESSURE UPON INSERTION. ALTHOUGH THIS IMPLANT WAS USED DURING SURGERY, 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 W07D5739

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK