BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPORE HEX IMPLANT

    MDR report key: 85670 · Received April 18, 1997

    Report

    Report Number
    2029012-1997-00090
    Event Type
    Injury
    Date Received
    April 18, 1997
    Date of Event
    October 17, 1996
    Report Date
    April 17, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE PATIENT DEVELOPED AN INFECTION TWO DAYS POST-IMPLANTATION. BONE LOSS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPORE HEX IMPLANT Implant ENDOSSEOUS DENTAL IMPLANT DZE INTERPORE INTL. NA 601002

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention