BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOIDE

    MDR report key: 100973 · Received June 24, 1997

    Report

    Report Number
    2029012-1997-00093
    Event Type
    Injury
    Date Received
    June 24, 1997
    Report Date
    June 9, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    LMN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING PRO OSTEON IMPLANT 500 GRANULES. IT WAS REPORTED THAT THE PRO OSTEON GRANULES WERE USED IN THE REPAIR OF A COMMINUTED CALCANEAL FRACTURE. SUBSEQUENTLY, THE PT DEVELOPED WOUND NECROSIS AT THE INCISION SITE, WHICH WAS CULTURED AND TESTED POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS AND ENTEROBACTER. THE PT WAS PLACED ON A COURSE OF INTRAVENOUS ANTIBIOTICS AND APPEARED TO BE DOING WELL FOR SIX TO SEVEN WEEKS. THE PT CONTINUED TO HAVE WOUND HEALING PROBLEMS AND INFECTION DEVELOPED AROUND THE SOFT TISSUE. THE PT THEN SAW DR. DR. DEBRIDED AND IRRIGATED THE WOUND, HOWEVER, THE PT CONTINUED TO SHOW SIGNS OF INFECTION. THEREFORE, WITHIN THE LAST TWO MONTHS, DR. REMOVED THE PLATE AND GRAFT AND PACKED THE AREA WITH ANTIBIOTIC BEADS. DR. REPORTED THAT THE PRO OSTEON WAS FULLY INCORPORATED BEFORE IT WAS REMOVED, AND THAT HE DID NOT SEE ANY EVIDENCE OF INFECTION INVOLVING THE PRO OSTEON, THEREFORE, HE DID NOT CULTURE IT. DR. ALSO STATED THAT THE PRO OSTEON WAS NOT THE CAUSE OF THE INFECTION, BUT WAS THE RESULT OF A WOUND HEALING COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOIDE Implant ENDOSSEOUS IMPLANT LMN INTERPORE INTL. NA 600604

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention