BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOSSOM DENTAL IMPLANT

    MDR report key: 8220443 · Received January 4, 2019

    Report

    Report Number
    3003631996-2018-00976
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    January 24, 2018
    Report Date
    January 4, 2019
    Manufacturer
    INTRA-LOCK INTERNATIONAL, INC.
    Product Code
    DZE
    PMA / PMN Number
    K103194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DR. IDENTIFIED FAILURE TO OSSEOINTEGRATE AS THE ISSUE. X-RAYS AND IMPLANT NOT PROVIDED TO INTRA-LOCK INTERNATIONAL, INC. FOR EVALUATION.

    Description of Event or Problem · 1

    DR. PLACED IMPLANT ON (B)(6) 2018. PATIENT RETURNED (B)(6) 2018 WITH MOBILITY ISSUES. IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9543 BLOSSOM DENTAL IMPLANT DENTAL IMPLANT DZE INTRA-LOCK INTERNATIONAL, INC. BLCT4710S BP475

    Patients

    Seq Age Sex Outcome Treatment
    1 Other