BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT, BLACK MAX

    MDR report key: 3061282 · Received April 10, 2013

    Report

    Report Number
    1045834-2013-01369
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 13, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 THE DEVICE WAS "GETTING HOT" DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY. THERE WAS A SHORT DELAY IN SURGERY BUT THE EXACT TIME WAS NOT PROVIDED. THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WERE NO INJURIES TO THE PT OR THE USER INJURIES REPORTED AND THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150029 MINIMAL ACCESS ATTACHMENT, BLACK MAX HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR