BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 3955270 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-06699
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    October 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    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 ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS OVERHEATING. THE DEVICE WAS USED DURING A SURGICAL PROCEDURE. IT IS KNOWN THAT THERE WAS NO USER OR PT INJURY. IT IS UNK IF MEDICAL INTERVENTION WAS REPORTED. IT IS UNK IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE EVENT. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654074 6.5CM ADULT CRANI ATTACHMT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1