BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.8X13MM MDI STANDARD O-BALL AND COLLAR

    MDR report key: 2021852 · Received March 8, 2011

    Report

    Report Number
    2110898-2011-00023
    Event Type
    Other
    Date Received
    March 8, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 9, 2011
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    DZE
    PMA / PMN Number
    K031106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS, RESULTS AND CONCLUSIONS: ONLY THE IMPLANT HEADS WERE RETURNED TO 3M ESPE. THE EVALUATION OF THESE PORTIONS OF THE IMPLANTS SHOWS EVIDENCE THAT THE IMPLANTS HAD BEEN OVER TORQUED, WHICH MAY HAVE BEEN A FACTOR IN THE REPORTED FAILURE.

    Description of Event or Problem · 1

    DURING PLACEMENT, THREE (B)(4)-IMPLANTS AND ONE (B)(4)-IMPLANT BROKE AND THE FRAGMENTS REMAINING IN THE BONE WERE REMOVED AT THE SAME DAY. THE DENTIST USED A TREPHINE DRILL AND SUCCESSFULLY REMOVED ALL FRAGMENTS. ACCORDING TO INFO PROVIDED BY THE DENTAL PROFESSIONAL, THE HEALTH STATUS OF THE PT IS FINE AND SHORTER IMPLANTS WERE SUCCESSFULLY IMPLANTED IN PLACE OF THE BROKEN ONES. THE IMPLANTS WERE INSERTED WITH A WING SCREW DEVICE AND NOT WITH A TORQUE WRENCH. IT IS NOT CLEAR BASED ON THE INFO PROVIDED WHETHER THE DENTAL PROFESSIONAL HAD DRILLED A PILOT HOLE OR WAS TRYING TO ALLOW THE IMPLANTS TO SELF-TAP. IT WAS NOTED THAT THE PT HAD D1 OR VERY DENSE BONE AND USE OF A PILOT HOLE WOULD BE REQUIRED FOR PLACEMENT.

    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 03510092-51

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other