BEUDAMED
    FDA Adverse Event Summary report: N

    DENTAL IMPLANT

    MDR report key: 18638 · Received December 30, 1994

    Report

    Report Number
    MW1004608
    Date Received
    December 30, 1994
    Date of Event
    October 17, 1994
    Report Date
    December 28, 1994
    Manufacturer
    DENTSPLY INTERNATIONAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT WAS PLACED IN TOOTH AREA #19 ON 11/8/93. THE AREA WAS UNCOVERED ON 3/2/94, AT WHICH TIME THE BONE WAS NOTED TO BE HEALTHY AND GROWING OVER THE TOP OF THE IMPLANT. THE CROWN WAS PROBABLY PLACED IN 4/94. THE PT HAD THREE CROWNS REPLACED BECAUSE OF LOOSENING, ALTHOUGH ON 6/20/94, WHEN THE RPTR SAW THE PT EVERYTHING LOOKED HEALTHY. ON 10/17/94, THE PT WAS SEEN BECAUSE OF A LOOSE CROWN. CLINICAL AND X-RAY EVIDENCE SUGGESTED THAT THE IMPLANT WAS FRACTURED. THE RPTR STATED THAT THE IMPLANT HAD SPLINTERED AT THE TOP AND THERE WAS NO BONE WHERE THE IMPLANT HAD SPLINTERED. UPON REMOVAL OF THE TOP PORTION OF THE IMPLANT, THE RPTR NOTED THAT THE BONE AROUND THE IMPLANT LOOKED HEALTHY. THE RPTR STATED THAT THE IMPLANT WAS PUT TO SLEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL IMPLANT Implant DZE DENTSPLY INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR