BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLOGENIX PUTTY

    MDR report key: 794674 · Received December 12, 2006

    Report

    Report Number
    1032347-2006-00039
    Event Type
    Other
    Date Received
    December 12, 2006
    Date of Event
    November 11, 2006
    Report Date
    November 15, 2006
    Manufacturer
    INTERPORE CROSS
    Product Code
    LMO
    PMA / PMN Number
    K031399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM FACILITY (HOSPITAL) BUT HAS NOT BEEN RECEIVED AT THIS TIME. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    TUMOR RESECTION. ALLOGENIX IMPLANTED (2006) IN CRANIOTOMY CUT LINES AND AROUND THE THINFLAP PLATES. SEVERAL DAYS LATER, PATIENT BECAME LETHARGIC. DOCTOR FOUND FLUID BUILD UP, WHAT APPEARED TO BE PUS. CULTURE PROVED TO BE INFECTION. REMOVED REMAINING ALLOGENIX, DEBRIDED, IRRIGATED AND CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOGENIX PUTTY DEMINERALIZED BONE LMO INTERPORE CROSS * 198722

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization PLATES AND SCREWS (DO NOT KNOW PART NUMBERS)