BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3061423 · Received April 10, 2013

    Report

    Report Number
    1045834-2013-01481
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE'S HOSE WAS "PINCHED OFF WHEN IT WAS SECURED TO THE MAYO STAND; THIS CAPTURED AIR FLOW RESTRICTIONS AND THE DEVICE TO MALFUNCTION" DURING SPINE SURGERY. THERE WERE NO DELAYS REPORTED AND ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153223 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1