BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8 X 13 MM MDI COLLARED SQUARE HEAD

    MDR report key: 3003840 · Received March 12, 2013

    Report

    Report Number
    3005174370-2013-00006
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    DZE
    PMA / PMN Number
    K031106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS RETURNED IN TWO PIECES FOR EVAL. EVAL OF THE FRACTURED SURFACE SHOWS TORSIONAL FAILURE. THE DENTIST REPORTED USING A RATCHET WRENCH TO PLACE THE IMPLANT. TH 3M ESPE INSTRUCTIONS FOR USE RECOMMEND USING A TORQUE WRENCH AND TO KEEP THE MAXIMUM AMOUNT OF FORCE TO LESS THAN 35 N-CM WHEN PLACING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, 3M ESPE WAS INFORMED THAT AN MDI IMPLANT FRACTURED DURING PLACEMENT. THE IMPLANT, WHICH WAS BEING PLACED IN D1 (DENSE) MANDIBULAR BONE, FRACTURED AS THE DENTIST WAS PLACING IT WITH A RATCHET WRENCH. THE DENTIST ATTEMPTED TO REMOVE THE FRACTURED PORTION OF THE IMPLANT AND WAS UNSUCCESSFUL, S THE PT WAS REFERRED TO AN ORAL SURGEON. UPON FOLLOW-UP, THE DENTIST REPORTED THAT THE ORAL SURGEON "DRILLED A HOLE DOWN" AND REMOVED THE FRACTURED IMPLANT; THE REPORTING DENTIST DID NOT HAVE FURTHER INFORMATION ABOUT THE TECHNIQUES USED TO REMOVE THE FRACTURED IMPLANT. THE SITE WAS AUGMENTED WITH SYNTHETIC BONE AND BEING ALLOWED TO HEAL BEFORE ATTEMPTING ANOTHER IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103350 1.8 X 13 MM MDI COLLARED SQUARE HEAD DENTAL IMPLANT DZE 3M ESPE DENTAL PRODUCTS SH-13 N326689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention