BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 2820107 · Received November 1, 2012

    Report

    Report Number
    2246640-2012-00034
    Event Type
    Injury
    Date Received
    November 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WITHOUT ADDITIONAL DEVICE INFORMATION, NO REVIEW OF THE DEVICE HISTORY RECORD WAS POSSIBLE, AND WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON USED RESORBABLE ALLOGRAFT BONE VOID FILLER DURING A WRIST SURGERY OF UNDETERMINED TYPE, AND THE GRAFT ALLEGEDLY "FAILED." NO ADDITIONAL PT OR DEVICE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MBP OSTEOTECH, INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other