BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THD IMPLT 5D X 10MM HA/HL

    MDR report key: 9867374 · Received March 23, 2020

    Report

    Report Number
    2027971-2020-06055
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    August 6, 2019
    Report Date
    March 4, 2020
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    PMA / PMN Number
    K883373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327766 THD IMPLT 5D X 10MM HA/HL ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA, LLC 335260

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention