BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8X18MM MDI O-BALL PROSTHETIC HEAD

    MDR report key: 3093647 · Received May 1, 2013

    Report

    Report Number
    3005174370-2013-00013
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 2, 2013
    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: THE FRAGMENTS OF THE FRACTURED IMPLANT INVOLVED IN THIS CASE WERE RETURNED TO 3M ESPE FOR EVALUATION. A LIGHT MICROSCOPICAL EXAMINATION OF THE RETURNED FRAGMENT REVEALED A HOMOGENOUS SURFACE ON THE FRACTURED SURFACE, WHICH IS TYPICAL FOR A BREAKAGE BECAUSE OF TOO HIGH TURNING MOMENT. AN INTERVIEW WITH THE DENTIST REVEALED THAT THE REASON FOR THE BREAKAGE WAS A HANDLING ERROR. THE PREDRILLING WAS INSUFFICIENT, WHICH LED TO AN ENHANCED RETARDING FORCE AND IN CONSEQUENCE, TO THE BREAKAGE OF THE IMPLANT. IN A FOLLOW-UP TELEPHONE CALL, THE SURGERY ASSISTANT STATED THAT THE PATIENT IS DOING FINE WITHOUT ANY ONGOING SYMPTOMS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED TO 3M ESPE THAT ONE MDI S1818OB-IMPLANT BROKE DURING IMPLANTATION AND HAD TO BE REMOVED BY OSTEOTOMY THE SAME DAY. THE DENTIST USED A TREPHINE DRILL FOR THIS. THE TREATMENT WAS DONE WITHOUT COMPLICATIONS. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189418 1.8X18MM MDI O-BALL PROSTHETIC HEAD DENTAL IMPLANT DZE 3M ESPE DENTAL PRODUCTS S1818OB N412689

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention