BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® CERTAIN® IMPLANT 5 X 11.5MM

    MDR report key: 4242789 · Received November 11, 2014

    Report

    Report Number
    0001038806-2014-00137
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK063341
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER PROVIDED SO INVESTIGATION LIMITED TO VISUAL INSPECTION OF THE RETURNED COMPONENT WHICH REVEALED DAMAGE CONSISTENT WITH REMOVAL. DAMAGE ALSO TO THE HEX OF THE IMPLANT CONSISTENT WITH ATTEMPTED RETRIEVAL OF THE FRACTURED RETAINING SCREW. UNABLE TO INDICATE A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ABUTMENT SCREW FRACTURED IN FIXTURE, COULD NOT BE RETRIEVED AND IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725112 OSSEOTITE® CERTAIN® IMPLANT 5 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I N/A 2006061026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention