BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADLT CRANI, THIN FT PLATE

    MDR report key: 2901505 · Received January 3, 2013

    Report

    Report Number
    1045834-2013-00027
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING "THE ATTACHMENT RUNS ROUGH AND HEATING". THE DEVICE WAS USED DURING A "CRANIOTOMY FOR TUMOR" PROCEDURE. THERE WERE NO PT OR USER INJURIES REPORTED. THE EXACT DAY OF THE EVENT WAS UNKNOWN TO THE REPORTER. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171 6.5CM ADLT CRANI, THIN FT PLATE HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1