BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCODE

    MDR report key: 3010766 · Received March 13, 2013

    Report

    Report Number
    MW5029389
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN ENCODE HEALING ABUTMENT WAS PLACED ON (B)(6) 2013. AN ATTEMPT TO REMOVE WAS MADE ON (B)(6) 2013 BY A GENERAL DENTIST (B)(6), WHICH LASTED 45 MINUTES AND WAS UNSUCCESSFUL. THE ORAL SURGEON WHO PLACED THE ABUTMENT (B)(6) ATTEMPTED TO REMOVE IT ON (B)(6) 2013. AFTER AN HOUR OF UNSUCCESSFUL ATTEMPTS, I UNDERWENT IV SEDATION AND AFTER ANOTHER 1.5 HOURS THE ABUTMENT WAS REMOVED. THE PROBLEM WAS APPARENTLY STRIPPED THREADS IN THE ABUTMENT. THIS PRODUCT CAUSED GREAT INCONVENIENCE, DISCOMFORT AND THE PERFORMANCE OF A CONSCIOUS SEDATION WITH IT'S ATTENDANT RISKS. DATES OF USE: (B)(6) 2013 - (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: DENTAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106369 ENCODE HEALING ABUTMENT NHA BIOMET 3I UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other