BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE - 60MM

    MDR report key: 2251288 · Received September 12, 2011

    Report

    Report Number
    3008657535-2011-00035
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 12, 2011
    Manufacturer
    INTEGRA, MEDINA
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PATIENT WHO HAD A PREVIOUS THREE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGICAL PROCEDURE HAD A FALL OUT OF BED. THE PATIENT'S BONE IS EXTREMELY OSTEOPOROTIC. AS A RESULT OF THE FALL, THE IMPLANTED PLATE HAD PARTIALLY SEPARATED FROM THE BOTTOM OF THE CONSTRUCT. THE SURGEON ELECTED TO REMOVE THE BOTTOM TWO SCREWS AND REPLACE THEM WITH RESCUE SCREWS. DURING THE SPINAL SURGERY PROCEDURE, WHEN HE TRIED TO USE THE REMOVAL TOOL HE WAS UNABLE TO UNSCREW THE SCREWS AND HOLD THE REMOVAL TOOL IN PLACE. HE TRIED UNSUCCESSFULLY TO USE A NERVE HOOK AND THE OTHER DRIVER THAT EXPANDS IN THE SCREW HEAD TO MOVE THE SCREW HEAD RETAINING ARM TAB. ULTIMATELY, HE DRILLED OFF THE TAB AND WAS ABLE TO REMOVE THE SCREWS. HE THEN ELECTED TO REPLACE THE WHOLE PLATE DUE TO THE FACT THAT THE TABS ON THE BOTTOM WERE DRILLED OFF. THREE OF THE OTHER EIGHT SCREWS WERE REMOVED WITH THE REMOVAL DEVICE AND FOUR WERE REMOVED BY DRILLING THE TAB OFF. ONE REMAINED IN THE PLATE WHEN HE REMOVED IT. HE THEN PLACED A MEDTRONIC PLATE ON WITH RESCUE SCREWS. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE - 60MM MANTARAY KWQ INTEGRA, MEDINA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention