BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FI

    MDR report key: 112373 · Received August 8, 1997

    Report

    Report Number
    2029012-1997-00096
    Event Type
    Injury
    Date Received
    August 8, 1997
    Date of Event
    October 26, 1995
    Report Date
    July 10, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    LMN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D INVOLVING PRO OSTEON IMPLANT 500 BLOCK USED TO REPAIR A PROXIMAL TIBIAL FRACTURE. SUBSEQUENTLY, THE PT DEVELOPED AN INFECTION. A CULTURE OF THE WOUND TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PT WAS TREATED WITH MULTIPLE DEBRIDEMENTS AND ANTIOBIOTICS WITH SUBSEQUENT REMOVAL OF THE METAL PLATE AND SCREWS AND EVENTUAL REMOVAL OF THE PRO OSTEON. THE DR REPORTED THAT THE PRO OSTEON WAS NOT THE CAUSE OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FI Implant ENDOSSEOUS IMPLANT LMN INTERPORE INTL. NA 500202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention