BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL 17 DEGREE ANGLED ABUTMENT

    MDR report key: 867928 · Received March 23, 2007

    Report

    Report Number
    1038806-2007-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    March 9, 2007
    Report Date
    March 9, 2007
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K063403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PROBLEM WAS RESTRICTED TO INTERNATIONAL SALES ONLY - NO PRODUCT WAS DISTRIBUTED IN THE US. DIMENSIONAL MEASUREMENTS AND MATING COMPONENTS CHECK. THE PART DRAWING CONTAINED A FEATURE CALLED OUT AS A REFERENCE DIMENSION. THE REFERENCE DIMENSION SHOULD HAVE BEEN A DIMENSION WITH TOLERANCES WHICH LEAD TO INADEQUATE MACHINING OF THE WALL THICKNESS.

    Description of Event or Problem · 1

    THE PROBLEM OCCURRED AT A PHYSICIAN'S FACILITY DURING PLACEMENT OF THE CONICAL 17 DEGREE ANGLED ABUTMENT (AC4217 LOT #639098F-5) ONTO AN IMPLANT. THE CLINICIAN EXPERIENCED THREE SEPARATE OCCASIONS WHERE THE UNITS WOULD NOT FUNCTION PROPERLY. IT WAS REPORTED BY THE DISTRIBUTOR THAT WHILE PLACING THE ABUTMENT AND INSERTING THE RETAINING SCREW AT APPROXIMATELY THE FIRST THREAD, THE PHYSICIAN STATED THERE WAS NO SUPPORT AND THE ABUTMENT FRACTURED. THERE WAS NOT ENOUGH MATERIAL IN THE THREADED PORTION OF THE ABUTMENT CONE AND THE RESULT WAS STRIPPING OF THE THREADS IN THE CONE. THIS OCCURRED AT THE INTERFACE OF THE GSH RETAINING SCREW AND ABUTMENT WHEN TORQUE WAS PLACED ON THE SCREW. PRODUCT EVALUATION DETERMINED THAT THE WALL WHERE THE RETAINING SCREW IS PLACED WAS MACHINED TOO THIN, THEREBY EXPOSING THE INTERNAL THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONICAL 17 DEGREE ANGLED ABUTMENT ABUTMENT (NHA) NHA BIOMET 3I * 639098F-5

    Patients

    Seq Age Sex Outcome Treatment
    1 *