BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 2003398 · Received March 1, 2011

    Report

    Report Number
    1030489-2011-00212
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 28, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRIALS WERE NOT RETURNED FOR EVALUATION. VISUAL AND OPTICAL EXAMINATION OF IMPLANT REVEALS LIGHT SURFACE SCRATCHES, CONSISTENT WITH EXPLANTATION. DIMENSIONAL EVALUATION OF SPHERICAL FEATURE HEIGHT, OVERALL HEIGHT, AND OVERALL WIDTH WERE ALL FOUND TO BE WITHIN SPRINT SPECIFICATION. VISUAL COMPARISON OF PROFILE OF INFERIOR PORTION OF IMPLANTS TO SAMPLE PRODUCT DID NOT IDENTIFY ANY ISSUE WITH RESPECT TO OVERALL PROFILE OF IMPLANT. UNABLE TO IDENTIFY MATERIAL OR FUNCTIONAL DEFECT WITH RESPECT TO THE IMPLANT. AFTER VISUAL, OPTICAL AND DIMENSIONAL EVALUATION, THE IMPLANT FUNCTIONS AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON USED THE TRIALS AND ALL LOOKED WELL BUT THE DISC WAS TOO SMALL WHEN IMPLANTED AND HE NEEDED TO REMOVE THE DISC AND GO TO A LARGER SIZE DISC. ALTHOUGH THE DEVICE WAS USED INTRAOPERATIVELY THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDIC, INC. 0100964W

    Patients

    Seq Age Sex Outcome Treatment
    1