BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAGRAFT STRIP, 6X, FP

    MDR report key: 347719 · Received August 15, 2001

    Report

    Report Number
    2954918-2001-00010
    Event Type
    Injury
    Date Received
    August 15, 2001
    Date of Event
    July 12, 2001
    Report Date
    August 13, 2001
    Manufacturer
    MCGHAN MEDICAL (CONTRACT MANUFACTURER) FREMONT OPERATIONS
    Product Code
    MBO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFECTION CONTROL COORDINATOR OF HOSPITAL REPORTED TO NEUCOLL, INC. THE DETAILS OF 2 CONFIRMED CASES OF METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION FOLLOWING SPINAL FUSION SURGERY USING COLLAGRAFT STRIP 6X LOT 68605100. BOTH PTS PRESENTED WITH SYMPTOMS OF INFECTION AND WERE READMITTED TO THE HOSPITAL ABOUT 30 DAYS POST SURGERY. MRSA WAS ISOLATED FROM THEIR INCISION WOUND AND BLOOD CULTURES. BOTH WERE DISCHARGED AND REMAIN ON LONG TERM VANCOMYCIN ANTIBIOTIC TREATMENT. OTHER PTS AT THIS HOSP UNDERWENT SPINAL FUSION SURGERY WITHIN A ONE MONTH PERIOD IN 2001 IN WHICH THIS LOT OF COLLAGRAFT WAS USED. THERE REMAINS NO CONFIRMED EVIDENCE OF INFECTION IN ANY OF THESE OTHER PTS AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37136 COLLAGRAFT STRIP, 6X, FP BONE VOID FILLER MBO MCGHAN MEDICAL (CONTRACT MANUFACTURER) FREMONT OPERATIONS NA ZIMMER LOT 68605100

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R ANTIBIOTIC TREATMENT.| PTS ARE CURRENTLY RECEIVING LONG TERM VANCOMYCIN,