BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERIOR PLATE

    MDR report key: 2031751 · Received February 25, 2011

    Report

    Report Number
    2520274-2011-00036
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    February 3, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. SYNTHES IS UNABLE TO PROVIDE THE PMA/510K NUMBER, EXPIRATION DATE AND THE DATE OF MANUFACTURE AT THIS TIME. IT WILL BE DETERMINED IN THE DEVICE HISTORY RECORDS REVIEW: DHR REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    PATIENT PARTICIPATED IN A (B)(6) STUDY PROGRAM, IMPLANTATION, LEVELS L4-L5 AND L5-S1, AND RECEIVED SURGERY ON (B)(6) 2004 AT (B)(6). ON A FOLLOW UP VISIT, DATE UNKNOWN, PATIENT PRESENTED WITH CONTINUED PAIN. PATIENT WAS ADVISED TO CONTINUE PAIN MANAGEMENT. NO ADDITIONAL MEDICAL TREATMENT WAS PROVIDED. THIS IS FIVE OF SIX REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERIOR PLATE SUPERIOR PLATE MJO SYNTHES (USA) NA 51175876

    Patients

    Seq Age Sex Outcome Treatment
    1 PE INLAY| INFERIOR PLATE