BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMLOG SCREW LINE IMPLANT PROMOTE PLUS

    MDR report key: 11810599 · Received May 12, 2021

    Report

    Report Number
    9613866-2020-33232
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    December 2, 2019
    Report Date
    March 2, 2020
    Manufacturer
    ALTATEC GMBH
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RE-SUBMISSION AS THE ORIGINAL REPORTS SUBMITTED 2020/01/13 AND 2020/03/02 DID NOT PASS FDA GATEWAY. PROBLEM SOLVED IN THE MEANTIME.

    Description of Event or Problem · 1

    IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706936 CAMLOG SCREW LINE IMPLANT PROMOTE PLUS CAMLOG SCREW LINE IMPLANT PROMOTE PLUS DZE ALTATEC GMBH K1052.3811 0040063524

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention