BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3811910 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-06052
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    April 19, 2012
    Report Date
    April 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED OR IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WOULD NOT RUN. THE DEVICE WAS BEING USED DURING SPINAL SURGERY, BUT NO INJURIES OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523811 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE, PRODUCT CODE: ERL ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1