BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1010164 · Received March 6, 2008

    Report

    Report Number
    1030489-2008-00122
    Event Type
    Malfunction
    Date Received
    March 6, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION FOUND THAT THE EYELET POST WAS SHEARED DUE TO APPLICATION OF TORQUE THAT EXCEEDED POST LIMITS. PART APPEARS TO MEET ALL MANUFACTURING SPECIFICATIONS. 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 CENTER NUT OF THE CROSSLINK SNAPPED UPON 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 W07L1560

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK