BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT SCREW

    MDR report key: 5090808 · Received September 16, 2015

    Report

    Report Number
    MW5056300
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 16, 2015
    Manufacturer
    NOBEL BIOCARE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A NOBEL BIOCARE TITANIUM IMPLANT (SIZE 3.0 BY 11.5) PLACED IN 2014. ABOUT A YEAR LATER, I HAD THE SCREW AND CROWN PUT IN. JUST OVER A WEEK LATER, THE CROWN CAME OUT. THE SCREW HAD BROKEN AT THE JUNCTURE WHERE THE SCREW PART GETS LARGER AND IS "HOLLOW" TO ALLOW THE WRENCH TO TORQUE IT IN TIGHTLY. I HAD BEEN EATING AN ALMOND AND FELT SOMETHING WAS NOT RIGHT WITH THE NEW CROWN. THE DENTIST REMOVED THE BROKEN PART OF THE SCREW FROM THE IMPLANT AND PLACED A NEW SCREW, BUT HAD TO DRILL INTO THE BRAND NEW CROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614372 IMPLANT SCREW IMPLANT SCREW HWC NOBEL BIOCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention