BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THD IMPLT 5D X 8MM TPS/HL

    MDR report key: 9064029 · Received September 15, 2019

    Report

    Report Number
    2027971-2019-02054
    Event Type
    Injury
    Date Received
    September 15, 2019
    Date of Event
    February 26, 2019
    Report Date
    May 30, 2019
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER: (B)(4). REVOKED ASR EXEMPTION NUMBER E1997036 "REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION".

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857062 THD IMPLT 5D X 8MM TPS/HL ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA, LLC 349560

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention