BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED INTERNAL IMPLANT

    MDR report key: 11131767 · Received January 6, 2021

    Report

    Report Number
    MW5098718
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    March 1, 2018
    Report Date
    January 5, 2021
    Manufacturer
    BIOHORIZON IMPLANT SYSTEMS, INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A DENTAL IMPLANT ON (B)(6) 2015. THE SCREW THAT IS ANCHORED IN MY GUM BROKE ON 4 OCCASIONS SINCE THEN AND MY TOOTH FELL OFF. THE SCREWS BROKE AND I RETURNED TO THE DENTIST FOR REPAIR ON (B)(6) 2018, (B)(6) 2018, (B)(6) 2019 AND (B)(6) 2020. EACH TIME I RETURNED WHEN THE TOOTH BROKE OFF, THE SCREW HAD BROKEN. THE DENTIST HAD TO GET THE BROKEN SCREW OUT OF MY GUM. WHEN I RETURNED EACH TIME WHEN THE TOOTH CAME OFF, I HAD TO GET MY GUM LASERED SINCE THE GUM GREW OVER THE IMPLANT SCREW. THIS CAUSED A LOT OF PAIN AFTERWARDS. I ALSO HAD TO PAY FOR SERVICES NOT COVERED BY MY INSURANCE EACH TIME. THE DENTIST SAID THAT THE REASON WHY IT BROKE SO MANY TIMES WAS BECAUSE I WAS GRINDING MY TEETH. THE COMPANY TOLD HIM TO ADJUST MY BITE BY SHAVING OFF SOME OF MY TOOTH BUT THIS DIDN'T HELP. THE IMPLANT CAME FROM A COMPANY CALLED (B)(4). IT¿S A TAPERED INTERNAL IMPLANT TLR4612. THE LOT REF # IS (B)(4). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19311 TAPERED INTERNAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZON IMPLANT SYSTEMS, INC. TLR4612 1405313
    19312 TAPERED INTERNAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZON IMPLANT SYSTEMS, INC.
    19313 TAPERED INTERNAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZON IMPLANT SYSTEMS, INC.
    19314 TAPERED INTERNAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZON IMPLANT SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other