BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 1181908 · Received September 19, 2008

    Report

    Report Number
    1030489-2008-00534
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 21, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE SCREWS WERE NOT RETURNED TO THE MANUFACTURE 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 LOCK SCREWS WOULD NOT ENGAGE THE SUPERIOR COMPONENT OF THE ARTIFICIAL CERVICAL DISC. THE SURGEON ELECTED TO LEAVE THE DEVICE IMPLANTED WITHOUT A LOCKING SCREW IN THE SUPERIOR COMPONENT. THE SURGEON REPORTEDLY ATTEMPTED TO ENGAGE MULTIPLE LOCK SCREWS WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM CERVICAL DISC MJO WARSAW ORTHOPEDIC INC. NA W07K0079

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR