BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MDI COLLARED INTERMEDIATE O-BALL 2.1MM X 13MM

    MDR report key: 4012507 · Received August 12, 2014

    Report

    Report Number
    3005174370-2014-00024
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    October 18, 2012
    Report Date
    July 14, 2014
    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

    THIS INCIDENT APPEARS TO BE RELATED TO INSUFFICIENT PRE-DRILLING OF THE PILOT HOLE WHICH MAY HAVE LED TO AN INCREASED FORCE BEING PLACED ON THE IMPLANT DURING IMPLANTATION, WHICH THEN LED TO THE FRACTURE. THE IMPLANT FRAGMENTS WERE EXAMINED VISUALLY USING A LIGHT MICROSCOPE. THE FRACTURED SURFACE WAS HOMOGENEOUS AND SHOWS THE TYPICAL PICTURE OF A FRACTURE CAUSED BY EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO 3M ESPE THAT A MDI COLLARED INTERMEDIATE O-BALL 2.1MM X 13MM ((B)(4)) BROKE DURING IMPLANTATION ON POSITION 41 AND THE APICAL FRAGMENT WAS REMOVED IN AN ADDITIONAL SURGERY AT THE SAME DAY. THE FRAGMENT WAS REMOVED WITH A SURGICAL FRAISE WITHOUT ANY COMPLICATIONS. THE DENTIST STATED THAT THE PATIENT IS DOING FINE WITHOUT ANY ONGOING SYMPTOMS. 3M ESPE WAS INFORMED OF THIS EVENT ON JULY 14, 2014, WHICH OCCURRED ON (B)(6) 2012; THE IMPLANT HAD BEEN PLACED ON THE SAME DAY (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478854 MDI COLLARED INTERMEDIATE O-BALL 2.1MM X 13MM DENTAL IMPLANT DZE 3M ESPE DENTAL PRODUCTS IOB-13

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention