BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT: ENDOSEOUS IMPLANT

    MDR report key: 4924420 · Received July 9, 2015

    Report

    Report Number
    MW5044403
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    July 7, 2015
    Manufacturer
    ASTRA
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS EATING A PIECE OF SOFT CHOCOLATE DURING WHICH THE IMPLANT TO REPLACE TOOTH #3 FELL OUT OF ITS SOCKET THAT IS IMPLANTED INTO MY MANDIBLE. I WILL SEND PICTURES OF THE TOOTH (CROWN) THAT FELL OFF THEY SHOW WHERE THE SCREW FRACTURED. I PROMPTLY REMOVED IT FROM THE IMPLANT FROM MY MOUTH, WHICH PREVENT ME FROM SWALLOWING THE IMPLANT. THIS IS THE SECOND TIME THIS PARTICULAR IMPLANT HAS BROKEN. THE LAST INCIDENT WAS LESS THAN ONE YEAR AGO. THE SOCKET THAT IS IMPLANTED IN MY MANDIBLE STAYED IN PLACE. THE IMPLANTED SCREW FRACTURE ABOUT MIDWAY DOWN THE SCREW'S SHAFT. MEDICAL FOLLOW UP: THE IMPLANT IS BEING EXAMINED BY THE IMPLANTING DENTIST, DR. (B)(6). NOW I AM REALLY WORRIED THAT THE OTHER IMPLANTS WILL FRACTURE AND FALL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447817 DENTAL IMPLANT: ENDOSEOUS IMPLANT ABUTMENT SCREW DESIGN 3.5/4.0, M1.6 NHA ASTRA REF 24449 90811

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| S CITALOPRAM 40MG/DAY| LAMICTAL - 300MG/DAY| WELLBUTRIN 400MG/DAY