BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ¿ IMPLANT

    MDR report key: 19167149 · Received April 23, 2024

    Report

    Report Number
    3001617766-2024-006731
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    September 14, 2023
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACT
    Product Code
    DZE
    PMA / PMN Number
    K192221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MATERIAL NUMBER INFORMATION WAS NOT PROVIDED, HOWEVER BASED ON THE BATCH NUMBER PROVIDED THE FOLLOWING MATERIAL NUMBER WAS ASSOCIATED WITH IT. MATERIAL #: 853710U. BATHCH #: 221601.

    Description of Event or Problem · 0

    FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947094 UNKNOWN ¿ IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention