BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3011096 · Received March 14, 2013

    Report

    Report Number
    1045834-2013-00672
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 15, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FORM THE USA STATING THAT THE DEVICE HAD "LOW POWER" DURING A SPINE SURGERY. THERE WAS NO DELAY IN SURGERY. A SPARE XMAX DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108140 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1