BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMTEC MDI HYBRID IMPLANT

    MDR report key: 1854670 · Received September 29, 2010

    Report

    Report Number
    1645158-2010-00005
    Event Type
    Other
    Date Received
    September 29, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 15, 2010
    Manufacturer
    3M IMTEC CORP
    Product Code
    DZE
    PMA / PMN Number
    K081653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3M'S SURGICAL GUIDE DOES NOT RECOMMEND USE OF THE (B)(4) QUALITY BONE. THE DENTIST ALSO REPORTED THAT A TORQUE WRENCH WAS NOT USED. THE 3M RECOMMENDS THE USE OF A TORQUE WRENCH TO AVOID EXCEEDING THE MAXIMUM TORQUE OF THE IMPLANT DURING PLACEMENT. THE IMPLANTS INVOLVED IN THIS CASE WERE RETURNED TO 3M ESPE FOR EVALUATION. THERE WAS EVIDENCE OF DAMAGE CONSISTENT WITH THE PROCEDURE PERFORMED TO REMOVE THEM.

    Description of Event or Problem · 1

    DURING THE INSERTION OF TWO DENTAL IMPLANTS IN THE LOWER JAW, THE IMPLANTS BROKE IN THE HEAD REGION. AN OSTEOTOMY WAS PERFORMED TO REMOVE THE ROOT PIECES OF THE IMPLANT FROM THE BONE. THE DOCTOR REPORTED USING A TORPEDO BUR TO PERFORM THE OSTEOTOMY. AFTER THE IMPLANT PIECES WERE REMOVED A DIFFERENT TYPE OF IMPLANT WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMTEC MDI HYBRID IMPLANT DENTAL IMPLANT DZE 3M IMTEC CORP MII-OB15 035E10113

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other