BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO OSTEON IMPLANT 500 BONE VOID FILLER

    MDR report key: 103339 · Received July 3, 1997

    Report

    Report Number
    2029012-1997-00095
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    January 16, 1997
    Report Date
    June 9, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    LMN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING PRO OSTEON IMPLANT 500 GRANULES USED TO REPAIR A FRACTURE OF THE LEFT PROXIMAL TIBIA. THE PT SUBSEQUENTLY DEVELOPED AN INFECTION AND THE HARDWARE AND PRO OSTEON WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON IMPLANT 500 BONE VOID FILLER Implant ENDOSSEOUS IMPLANT LMN INTERPORE INTL. NA 517709

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention