BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1213700 · Received October 23, 2008

    Report

    Report Number
    1030489-2008-00592
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Report Date
    September 29, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE CENTER EYELET SHEARED OFF SUGGESTING OVER-TORQUE. 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 LOCK NUT OF THE CROSSLINK SHEARED OFF DURING IMPLANT IN SURGERY. THE IMPLANT WAS REPLACED WITH NO FURTHER COMPLICATIONS. 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 W07E4280

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK