BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5153549 · Received October 15, 2015

    Report

    Report Number
    0001038806-2015-00823
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    April 10, 2014
    Report Date
    September 30, 2015
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS RETURNED AND VISUALLY INSPECTED. THERE WERE GENERAL SIGNS OF USAGE AND EVIDENCE OF REMNANT BONE ALONG THE IMPLANT. DUE TO THE CONDITION OF THE INTERIOR OF THE IMPLANT, THE SCREW FRAGMENT WAS NOT VISIBLE. THE REMAINDER PORTION OF THE SCREW WAS NOT RETURNED. DEVICE PRODUCT OR LOT INFORMATION FOR THE SCREW WAS NOT PROVIDED AND THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. THE DEVICE HISTORY RECORD REVIEW FOR THE IMPLANT LOT WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING DEVIATIONS WHICH WOULD RESULT IN OR CONTRIBUTE TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE DENTIST REPORTED A FRACTURED SCREW. THE DENTIST WAS UNABLE TO REMOVE THE BROKEN SCREW, THEREFORE THE IMPLANT WAS REMOVED AND A BONE GRAFT/GBR WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683540 UNKNOWN ABUTMENT SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention NIOSM311