BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMLOG SCREW LINE IMPLANT 3.8X13

    MDR report key: 2240612 · Received January 30, 2008

    Report

    Report Number
    9613866-2007-00053
    Event Type
    Injury
    Date Received
    January 30, 2008
    Date of Event
    November 29, 2007
    Report Date
    January 16, 2008
    Manufacturer
    ALTATEC GMBH
    Product Code
    DZE
    PMA / PMN Number
    K022425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE ISSUED A MEDICAL, TECHNICAL AND MECHANICAL EVALUATION. THE RESULT IS EXPECTED WITHIN THE NEXT 8 WEEKS. WE WILL SEND THE RESULTS AND CONCLUSIONS TO YOU AS SOON AS AVAILABLE.

    Description of Event or Problem · 1

    IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMLOG SCREW LINE IMPLANT 3.8X13 SCREW LINE IMPLANT DZE ALTATEC GMBH J1042.3813 020004021

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention