BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, SPLINE, 13MM, 3.25

    MDR report key: 92304 · Received May 22, 1997

    Report

    Report Number
    2023141-1997-00407
    Event Type
    Injury
    Date Received
    May 22, 1997
    Date of Event
    November 11, 1996
    Report Date
    April 30, 1997
    Manufacturer
    SULZER CALCITEK INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REPORTED AS CATALOG #: 1851 LOT#: 952727 WAS FOUND TO BE CATALOG #: 1852 LOT: UNKNOWN. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR'S OFFICE.

    Description of Event or Problem · 1

    DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED DUE TO INFECTION AND BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA, SPLINE, 13MM, 3.25 Implant HA CYLINDER ENDOSSEOUS DENTAL IMPLANT DZE SULZER CALCITEK INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention