BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPORE HEX IMPLANT

    MDR report key: 48412 · Received November 5, 1996

    Report

    Report Number
    2029012-1996-00039
    Event Type
    Injury
    Date Received
    November 5, 1996
    Date of Event
    August 16, 1996
    Report Date
    November 4, 1996
    Manufacturer
    INTERPORE INTL
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. BONE LOSS WAS NOTED. THE PT HAS EMPHYSEMA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention