BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSATILE IMPLANT

    MDR report key: 9892423 · Received March 28, 2020

    Report

    Report Number
    3013173272-2020-00001
    Event Type
    Injury
    Date Received
    March 28, 2020
    Report Date
    February 24, 2020
    Manufacturer
    SURGIKOR, LLC
    Product Code
    DZE
    UDI-DI
    D824PVRH42110
    PMA / PMN Number
    K152555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REPORT WAS PROVIDED WITH MUCH OF THE INFORMATION REQUIRED BY FORM 3500A MISSING. THIS WAS DESPITE THE COMPLAINT REPORT'S PROMPTING THE PROVISION OF SUCH INFORMATION. DATE OF MANUFACTURE IS SAID TO BE 11-1-2016 IN REPORT. BUT WE DO NOT ACTUALLY KNOW THE DAY, ONLY THE MONTH AND YEAR. THE PROGRAM REQUIRED THAT A DAY BE ENTERED, THOUGH. THIS REPORT WAS DELAYED BY DISRUPTIONS CAUSED BY THE CORONAVIRUS. DOCUMENTATION OF THIS IS ATTACHED.

    Description of Event or Problem · 1

    FAILURE OF TWO IMPLANTS. TEETH AFFECTED WERE 28 AND 29. SURGERY NECESSARY TO PREVENT DAMAGE. PATIENT NEEDED TO RETURN FOR ANOTHER DENTAL APPOINTMENT TO FINISH THE PROCEDURE (I.E., REPLACE IMPLANT). DUE TO EVENT, PATIENT EXPERIENCED MILD PAIN, AND WHAT WERE PRESUMABLY THE IMPLANTS (NOT CLEAR, BUT STRONGLY SUGGESTED) WERE SAID TO BE "LOOSE, NOT INTEGRATED." IMPLANTS WERE RESTORED. THE TWO IMPLANTS WERE PLACED TOO CLOSE TO EACH OTHER, AND THIS IS BELIEVED TO HAVE CAUSED THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358171 VERSATILE IMPLANT DENTAL IMPLANT DZE SURGIKOR, LLC VRH4211 14995 D824PVRH42110

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention