BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXUR M

    MDR report key: 2267109 · Received September 23, 2011

    Report

    Report Number
    2246640-2011-00015
    Event Type
    Other
    Date Received
    September 23, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 31, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE SUBJECT LOT OF PRODUCT WAS NOT POSSIBLE, AS NO LOT INFORMATION WAS PROVIDED. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE PROVIDED TO OSTEOTECH FOR EVALUATION. WE ARE THEREFORE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PLEXUR M IS A TERMINALLY STERILIZED PRODUCT.

    Description of Event or Problem · 1

    PT RECEIVED RESORBABLE BONE VOID FILLER DURING A LEFT FEMUR RECONSTRUCTION. FOUR MONTHS POST-OPERATIVELY, THE PT PRESENTED WITH PAIN, SWELLING, BUT NO EVIDENCE OF INFECTION WAS FOUND ON CULTURES. THE PT WAS GIVEN STEROIDS, THE SITE WAS DRAINED PERCUTANEOUSLY, AND NO REHOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MQV OSTEOTECH, INC. 6100-020 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention