BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXLOCK EXTREME MEDIAL MAX STANDARD PLATE

    MDR report key: 4524053 · Received February 11, 2015

    Report

    Report Number
    3005039508-2015-00001
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 20, 2015
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    PMA / PMN Number
    K123203
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Additional Manufacturer Narrative · 1

    DUE TO THE LACK OF INFORMATION PROVIDED AND THE FACT THAT THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    THE PLATE HAD BROKEN THROUGH A SCREW HOLE. A REVISION SURGERY WAS NECESSARY TO REMOVE THE PLATE. A NEW PLATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101990 MAXLOCK EXTREME MEDIAL MAX STANDARD PLATE NONE HRS ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention