BEUDAMED
    FDA Adverse Event Summary report: N

    ALLOGRAFT

    MDR report key: 256738 · Received December 29, 1999

    Report

    Report Number
    MW1017803
    Date Received
    December 29, 1999
    Date of Event
    January 1, 1999
    Report Date
    December 29, 1999
    Manufacturer
    ALLOSOURCE, INC.
    Product Code
    LMO
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THESE ALLOGRAFTS ARE CULTURED BEFORE THEY ARE IMPLANTED INTO PTS. THE GRAFTS FROM 4 PTS HAD PULSE FIELD GEL ANALYSIS DONE AND IT WAS FOUND THAT 2 PTS' ISOLATES WERE IDENTICAL (MRSA) AND 2 OTHER PTS' ISOLATES WERE IDENTICAL (MRSA). THIS SUGGESTS THERE COULD BE SOME COMMON CONTAMINATION. CO WAS NOTIFIED AND IS PLANNING AN INVESTIGATION. NOT CLEAR IF PROBLEM IS INTERNAL OR FROM CO. NONE OF THE PTS HAVE BECOME INFECTED. PTS 1 AND 2 IDENTICAL. PTS 3 AND 4 IDENTICAL. PT 1: 990974002, PT 2: 991026001, 990945004, 99029003, PT 3: 990549018, PT 4: 980492014. PT 1 HAD TIBIAL IMPLANT. PT 2 HAD TENDON IMPLANT. PT 3 HAD BONE CHIPS. PT 4 HAD BONE CHIPS.

    Description of Event or Problem · 2

    THESE ALLOGRAFTS ARE CULTURED BEFORE THEY ARE IMPLANTED INTO PTS. THE GRAFTS FROM 4 PTS HAD PULSE FIELD GEL ANALYSIS DONE AND IT WAS FOUND THAT 2 PTS' ISOLATES WERE IDENTICAL (MRSA) AND 2 OTHER PTS' ISOLATES WERE IDENTICAL (MRSA). THIS SUGGESTS THERE COULD BE SOME COMMON CONTAMINATION. CO WAS NOTIFIED AND IS PLANNING AN INVESTIGATION. NOT CLEAR IF PROBLEM IS INTERNAL OR FROM CO. NONE OF THE PTS HAVE BECOME INFECTED. PTS 1 AND 2 IDENTICAL. PTS 3 AND 4 IDENTICAL. PT 1: 990974002, PT 2: 991026001, 990945004, 99029003, PT 3: 990549018, PT 4: 980492014. PT 1 HAD TIBIAL IMPLANT. PT 2 HAD TENDON IMPLANT. PT 3 HAD BONE CHIPS. PT 4 HAD BONE CHIPS.

    Description of Event or Problem · 3

    THESE ALLOGRAFTS ARE CULTURED BEFORE THEY ARE IMPLANTED INTO PTS. THE GRAFTS FROM 4 PTS HAD PULSE FIELD GEL ANALYSIS DONE AND IT WAS FOUND THAT 2 PTS' ISOLATES WERE IDENTICAL (MRSA) AND 2 OTHER PTS' ISOLATES WERE IDENTICAL (MRSA). THIS SUGGESTS THERE COULD BE SOME COMMON CONTAMINATION. CO WAS NOTIFIED AND IS PLANNING AN INVESTIGATION. NOT CLEAR IF PROBLEM IS INTERNAL OR FROM CO. NONE OF THE PTS HAVE BECOME INFECTED. PTS 1 AND 2 IDENTICAL. PTS 3 AND 4 IDENTICAL. PT 1: 990974002, PT 2: 991026001, 990945004, 99029003, PT 3: 990549018, PT 4: 980492014. PT 1 HAD TIBIAL IMPLANT. PT 2 HAD TENDON IMPLANT. PT 3 HAD BONE CHIPS. PT 4 HAD BONE CHIPS.

    Description of Event or Problem · 4

    THESE ALLOGRAFTS ARE CULTURED BEFORE THEY ARE IMPLANTED INTO PTS. THE GRAFTS FROM 4 PTS HAD PULSE FIELD GEL ANALYSIS DONE AND IT WAS FOUND THAT 2 PTS' ISOLATES WERE IDENTICAL (MRSA) AND 2 OTHER PTS' ISOLATES WERE IDENTICAL (MRSA). THIS SUGGESTS THERE COULD BE SOME COMMON CONTAMINATION. CO WAS NOTIFIED AND IS PLANNING AN INVESTIGATION. NOT CLEAR IF PROBLEM IS INTERNAL OR FROM CO. NONE OF THE PTS HAVE BECOME INFECTED. PTS 1 AND 2 IDENTICAL. PTS 3 AND 4 IDENTICAL. PT 1: 990974002, PT 2: 991026001, 990945004, 99029003, PT 3: 990549018, PT 4: 980492014. PT 1 HAD TIBIAL IMPLANT. PT 2 HAD TENDON IMPLANT. PT 3 HAD BONE CHIPS. PT 4 HAD BONE CHIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOGRAFT Implant TENDON AND BONE ALLOGRAFT LMO ALLOSOURCE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA
    2 NA
    3 NA
    4 NA