BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL CROWN

    MDR report key: 16552320 · Received March 15, 2023

    Report

    Report Number
    MW5115771
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    December 6, 2022
    Report Date
    March 13, 2023
    Manufacturer
    UNK
    Product Code
    ELZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS TOLD I AM A GOOD CANDIDATE FOR INVISALIGN BY MY ORTHODONTIST. I HAVE TMJ (TEMPOROMANDIBULAR JOINT DISORDER) AND MULTIPLE CROWNS, IMPLANTS AND A BRIDGE. I HAVE HAD TOOTH AND JAW PAIN SINCE I STARTED AND MY TMJ HAS INCREASED. IN (B)(6) 2022 ONE OF MY CROWNS FRACTURED. AFTER SPENDING (B)(6) ON INVISALIGN, I NOW HAVE TO SPEND (B)(6) ON A CROWN. I AM SURE THERE WILL BE MORE REPAIR REQUIRED UNTIL I FINISH WEARING THEM (I HAVE BEEN WEARING THEM SINCE (B)(6) 2021. REFERENCE REPORT #MW5115770.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548564 DENTAL CROWN CROWN, PREFORMED ELZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female