BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD CRANIOTOME, BM

    MDR report key: 2896707 · Received December 28, 2012

    Report

    Report Number
    1045834-2012-00179
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    PMA / PMN Number
    K955084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADD¿L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THERE WAS A ¿LOOSE PART INSIDE¿ OF THE DEVICE. THE ITEM WAS SITTING ON A TRAY WITH A NOTE REQUESTING A REPAIR. THERE WAS NO ADD¿L INFO REGARDING WHETHER OR NOT THE DEVICE WAS USED IN SURGERY. THERE WAS NO ADD¿L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STD CRANIOTOME, BM HSZ THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1