BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO OSTEON IMPLANT 500 CORRALINE HYDROXYAPATITE BONE VOID FI

    MDR report key: 88830 · Received April 29, 1997

    Report

    Report Number
    2029012-1997-00091
    Event Type
    Injury
    Date Received
    April 29, 1997
    Report Date
    April 28, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    MBP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING DEVICE USED TO REPAIR A CALCANEOUS FRACTURE. THREE MONTHS POST-OPERATIVE, THE PT DEVELOPED AN INFECTION WITH CHRONIC DRAINAGE. THE DR CURETTED THE SURGICAL SITE AND REMOVED A PORTION OF THE DEVICE. THE PT HEALED AND IS PRESENTLY DOING WELL. THE DR DOES NOT RECALL THE PT'S NAME NOR DOES HE REMEMBER THE CAUSITIVE AGENT INVOLVED. THE DR STATED THAT LARGE FLAPS OF SKIN ARE PULLED BACK FOR THIS TYPE OF REPAIR PROCEDURE, AND A PLATE WITH SCREWS IS PLACED, THUS MAKING IT DIFFICULT TO DETERMINE AN EXACT CAUSE FOR INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention