BEUDAMED
    FDA Adverse Event Other Summary report: N

    TREPHINE BURR - 5MM INSIDE DIAMETER/6MM OUTS

    MDR report key: 242985 · Received September 28, 1999

    Report

    Report Number
    1038806-1999-00004
    Event Type
    Other
    Date Received
    September 28, 1999
    Date of Event
    July 19, 1999
    Report Date
    September 27, 1999
    Manufacturer
    IMPLANT INNOVATIONS, INC.
    Product Code
    DZA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SPOKE WITH USER FACILITY. WHEN DR TRIED TO REMOVE A 4MM IMPLANT USING THE TRE05 IT WOULD NOT CUT INTO THE BONE. THE RN WAS NOT ASSISTING IN THE SURGERY AND COULD NOT GIVE ANY MORE INFORMATION. CO EXPLAINED THAT IT MAY NOT BE AT FAULT WITH THE COMPONENT BUT RATHER WITH THE MANNER IT WAS USED, BUT THAT THE CO WOULD GO AHEAD AND INVESITGATE AND GET BACK TO THE USER FACILITY. WILL CALL USER FACILITY WITH RESULTS ALSO. COMPONENT INVOICE #8030403.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREPHINE BURR - 5MM INSIDE DIAMETER/6MM OUTS TRE05 DZA IMPLANT INNOVATIONS, INC. TRE05 80482

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other