BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3955404 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-15138
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED OR 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 DEVICE WAS PRODUCING HEAT. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MED INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654165 BLACKMAX-NEURO HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1