BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO OSTEON IMPLANT 500 HYDROXYAPATITE

    MDR report key: 37999 · Received September 9, 1996

    Report

    Report Number
    2029012-1996-00006
    Event Type
    Injury
    Date Received
    September 9, 1996
    Date of Event
    June 20, 1996
    Report Date
    September 6, 1996
    Manufacturer
    INTERPORE INTL.
    Product Code
    LMN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING IMPLANT. HYDROXYAPATITE BONE VOID FILLER BLOCK WAS USED TO REPAIR A SEVERELY COMMINUTED (SCHATZKER TYPE IV) PROXIMAL TIBIAL FRACTURE. THE PT DEVELOPED A NECROTIC WOUND DEHISCENSE APPROX 3 WKS POST-OPERATIVELY. THE DR STATED THAT THE PT'S HEAVY SMOKING HABITS CAUSED THE DEHISCENSE. THE PT RETURNED TO THE HOSP 3 TIMES FOR IRRIGATION AND DEBRIDEMENT. FOLLOWING THE LAST DEBRIDEMENT THE WOUND WAS CLOSED USING A FREE VASCULAR RECTUS GRAFT TRANSFERRED TO THE DEHISCENSE SITE. THE WOUND HEALED BUT CONTINUED TO DRAIN. THE PT WAS PLACED ON A 6 WK I.V. COURSE OF ANTIBIOTICS AND WAS DISCHARGED HOME. THE PT THEN CONTINUED ON ORAL ANTIBIOTICS. ADD'L SURGERY ON 6/20/96, NOTED INFECTION AND BONE NECROSIS. A CULTURE TAKEN AT THE TIME OF SURGERY TESTED POSITIVE FOR PEPTOSTREPTOCOCCUS. THE FILLER, LATERAL PLATE AND SCREWS, AND NECROTIC BONE WERE REMOVED. THE DR STATED THAT ALTHOUGH THE PRESENCE OF PRO OSTEON MAY HAVE EXACERBATED THE INFECTION (I.E. AN AREA WHERE THE INFECTION MIGHT HARBOR), THE SAME OUTCOME WOULD HAVE BEEN REACHED USING AUTOGRAFT THAT ULTIMATELY DID NOT VASCULARIZE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention