BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPORE HEX IMPLANT

    MDR report key: 85575 · Received April 15, 1997

    Report

    Report Number
    2029012-1997-00082
    Event Type
    Injury
    Date Received
    April 15, 1997
    Date of Event
    March 11, 1997
    Report Date
    April 15, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED OF AN ENDOSSEOUS DENTAL IMPLANT WHICH WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE PT HAS A BRUXING HABIT. SUPPARATION WAS NOTED. THE DR REPORTED THAT THE PT'S NEUROSIS WAS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPORE HEX IMPLANT Implant ENDOSSEOUS DENTAL IMPLANT DZE INTERPORE INTL. NA 511212

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention