BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 3063213 · Received April 11, 2013

    Report

    Report Number
    1045834-2013-01585
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND MET MFG SPECS. THE EVENT COULD NOT BE DUPLICATED, THEREFORE, THE EVENT WAS NOT CONFIRMED. 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 DURING SPINE SURGERY THE DEVICE WAS "HEATING UP. THERE WERE NO INJURIES REPORTED. THERE WAS A SPARE QD11 AVAILABLE FOR USE AND THERE WERE NO DELAYS TO THE SURGERY. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156446 11CM ANGLE ATTACHMENT ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1