BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 2883183 · Received December 18, 2012

    Report

    Report Number
    1045834-2012-00136
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND HAD A BROKEN PROTECTIVE FOOT. THIS WAS MOST LIKELY DUE TO THE PROTECTIVE FOOT AND BACK POST BEING DRILLED INTO DUE TO DEVICE BEING MISASSEMBLED AT CUSTOMER SITE. THE EVENT WAS CONFIRMED. 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 THAT THE "TIP BROKE OFF." THE TIP BROKE OFF DURING A "CRANI CASE." ALL OF THE PIECES WERE REMOVED. THERE WERE NO INJURIES REPORTED. THERE WERE NO DELAYS OR MEDICAL ATTENTION NEEDED. THERE WAS ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5CM ADULT CRANI ATTACHMT HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR