BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPORTE IMZ IMPLANT

    MDR report key: 83355 · Received April 9, 1997

    Report

    Report Number
    2029012-1997-00080
    Event Type
    Injury
    Date Received
    April 9, 1997
    Date of Event
    February 13, 1997
    Report Date
    April 9, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    TWO DENTAL IMPLANTS WERE EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. PERSISTANT PAIN WITH SLOWLY RESOLVING SWELLING WAS REPORTED. THERE WAS NO PURULENCE EVIDENT, BUT THE INCIDENT WAS TREATED AS AN INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention