BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD CRANIOTOME, BLACKMAX

    MDR report key: 3160065 · Received June 10, 2013

    Report

    Report Number
    1045834-2013-02412
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT FROM THE (B)(6) STATING THE DEVICE NEEDED SERVICE. IT IS UNKNOWN IF THE DEVICE WAS USED IN SURGERY. IT IS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260812 STANDARD CRANIOTOME, BLACKMAX BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1