BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3593167 · Received September 16, 2013

    Report

    Report Number
    1045834-2013-06936
    Event Type
    Malfunction
    Date Received
    September 16, 2013
    Report Date
    January 27, 2012
    Manufacturer
    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "DOES NOT WORK". THE DEVICE
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE IS CURRENTLY UNDERGOING EVAL. ONCE THE EVAL HAS BEEN COMPLETED OR IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "DOES NOT WORK". THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED AND THE DATE OF THE EVENT IS UNK AS WELL. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465944 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "DOES NOT WORK". THE DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1