BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® TAPERED IMPLANT 5/4 X 8.5MM

    MDR report key: 3943705 · Received July 18, 2014

    Report

    Report Number
    0001038806-2014-00057
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK122300
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION, FOUND THIS BOPT5485 IMPLANT LOOKED WELL USED AND WAS INTERNALLY AND EXTERNALLY DAMAGED. CAUSE UNDETERMINED. LIKELY CAUSE IS GENERAL MISHANDLING DUE TO IMPROPER PLACEMENT AND REMOVAL OF IIPDTS (NOT RETURNED). THE REVIEW OF THE DHR RECORDS DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CAUSE THIS CONDITION.

    Description of Event or Problem · 1

    DURING IMPLANTATION PROCEDURE IN TOOTH LOCATION #30, THE CLINICIAN INDICATED THE IMPLANT DRIVER (IIPDTS) GOT STUCK IN THE IMPLANT HEX AND COULD NOT BE REMOVED NECESSITATING REMOVAL OF IMPLANT. THE CLINICIAN REPORTED THAT THERE WAS NO SERIOUS PATIENT INJURY, NO DETERIORATION IN PATIENT¿S HEALTH AND NO CONTRIBUTING CONDITIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421583 3I T3® TAPERED IMPLANT 5/4 X 8.5MM 3I T3® TAPERED IMPLANT 5/4 X 8.5MM DZE BIOMET 3I N/A 1146840

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention