BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTATEC

    MDR report key: 19473182 · Received June 5, 2024

    Report

    Report Number
    1060818-2024-60421
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 13, 2024
    Manufacturer
    ALTATEC
    Product Code
    DZE
    UDI-DI
    E219C108538091
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE NEW SYSTEM REVEALED THIS RECORD WAS NOT SUBMITTED. THE SYSTEM HAS BEEN PROVIDING ERRORS DURING SUBMISSION. CORRECTION ACTION ¿ SUBMITTED RECORD ON DAY OF DISCOVERY. ALERT VENDOR OF ANY ERRORS RECEIVED DURING THE SUBMISSION OF THE RECORD FOR FURTHER RESEARCH AND INVESTIGATION. PREVENTATIVE ACTION ¿ RUN REPORT TO ENSURE RECORDS HAVE BEEN TRANSMITTED BY THEIR RESPECTIVE DUE DATE.

    Description of Event or Problem · 0

    IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.

    Description of Event or Problem · 0

    IMPLANT REMOVED, DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688320 ALTATEC DENTAL IMPLANT DZE ALTATEC C1085.3809 0030135303 E219C108538091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention