BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTCHMT

    MDR report key: 3984211 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16096
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    July 6, 2011
    Report Date
    July 6, 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 WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE WAS EVALUATED AND DURING SERVICE THE REPORTED CONDITION OF COSMETIC DAMAGE WAS CONFIRMED. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE REQUIRED SVC. DURING SERVICING OF THE DEVICE, A COSMETIC DEFECT WAS FOUND. IT IS UNK IF THE DEVICE WAS USED IN SURGERY. IT IS UNK IF THERE WERE ANY USER OR PT INJURIES DOCUMENTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663741 6.5CM ADULT CRANI ATTCHMT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1