BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.8X13MM MDI STANDARD O-BALL AND COLLAR

    MDR report key: 2792454 · Received October 10, 2012

    Report

    Report Number
    3005174370-2012-00023
    Event Type
    Other
    Date Received
    October 10, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 24, 2012
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    DZE
    PMA / PMN Number
    K031106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHODS, RESULTS, CONCLUSIONS: THE FRACTURE OCCURRED AT THE START OF THREADS, OCCURRING AT A SLIGHT ANGLE FROM PERPENDICULAR TO THE LONG AXIS OF THE IMPLANT. FRACTURE SURFACE SHOWS OFFSET TORSIONAL FAILURE AND ROUGHNESS CONSISTENT WITH OVER-TORQUING WITH SLIGHT CANTILEVER. AS INDICATED, THE DENTIST FAR EXCEEDED THE 3M ESPE FORCE RECOMMENDATIONS LISTED IN THE INSTRUCTIONS FOR USE. THE INSTRUCTIONS INDICATE NOT TO EXCEED 45 NCM OF FORCE DURING PLACEMENT; THIS DENTIST REPORTS THAT THE FORCE WAS AT 60 NCM WHEN THE IMPLANT BROKE.

    Description of Event or Problem · 1

    ON (B)(4) 2012, 3M ESPE WAS INFORMED THAT DURING AN IMPLANT PLACEMENT PROCEDURE, THE IMPLANT FRACTURED AND THE DENTIST REMOVED BONE AROUND THE FRACTURED IMPLANT IN AN ATTEMPT TO REMOVE THE FRACTURED IMPLANT. ONLY A PORTION OF THE IMPLANT WAS ABLE TO BE REMOVED AND AN APPROXIMATE 6 MM OF THE IMPLANT TIP WAS LEFT IN THE BONE. THE DENTIST REPORTED THAT HE DRILLED A PILOT HOLE IN TOOTH POSITION 27 APPROXIMATELY 5-6 MM IN DEPTH AND THEN ATTEMPTED TO PLACE A 1.8 X 13 MM IMPLANT. THE DENTIST REPORTS THAT UPON PLACEMENT, HE RAN INTO VERY DENSE BONE, AND AT APPROXIMATELY 10 MM OF DEPTH, THE FORCE MEASURED ON THE PLACEMENT WRENCH WAS 60 NCM (3M ESPE INSTRUCTIONS FOR USE INDICATE NOT TO EXCEED 45 NCM OF FORCE DURING PLACEMENT). IT WAS AT THAT POINT THAT THE IMPLANT BROKE. THE CLINICAL TREATMENT PLAN IS TO LEAVE THE FRAGMENT IN PLACE, ALLOW HEALING TO OCCUR AND ATTEMPT TO PLACE ANOTHER IMPLANT IN A NEW LOCATION WITH A DEEPER PILOT HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.8X13MM MDI STANDARD O-BALL AND COLLAR DENTAL IMPLANT DZE 3M ESPE DENTAL PRODUCTS OB-13 N369622

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other