BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-LOCK DENTAL IMPLANT

    MDR report key: 8456865 · Received March 27, 2019

    Report

    Report Number
    3003631996-2019-01197
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    March 15, 2019
    Report Date
    March 27, 2019
    Manufacturer
    INTRA-LOCK INTERNATIONAL, INC
    Product Code
    DZE
    PMA / PMN Number
    K103194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DR PLACED IMPLANT OM (B)(6) 2017. PATIENT RETURNED ON (B)(6) 2019 WITH MOBILITY ISSUES. IMPLANT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250893 INTRA-LOCK DENTAL IMPLANT DENTAL IMPLANT DZE INTRA-LOCK INTERNATIONAL, INC IC4310STI BQ072

    Patients

    Seq Age Sex Outcome Treatment
    1 Other