BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXUR M

    MDR report key: 2089553 · Received March 31, 2011

    Report

    Report Number
    2246640-2011-00010
    Event Type
    Other
    Date Received
    March 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION ON THIS FORM 3500A WAS COMPLETED USING THE INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT BEING PROVIDED BY THE REPORTER. OSTEOTECH'S MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER HAVE BEEN UNSUCCESSFUL, AND THUS WE ARE UNABLE TO THOROUGHLY COMPLETE THIS FORM 3500A. A REVIEW OF THE MANUFACTURING RECORDS FOR THE SUBJECT LOT OF PLEXUR M WAS NOT POSSIBLE AS NO LOT INFORMATION WAS PROVIDED BY THE REPORTER. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO OSTEOTECH FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLEXUR M HAD BEEN IMPLANTED IN THE PATIENT'S LEFT BIG TOE, AND AFTER AN UNKNOWN PERIOD OF TIME POST-OPERATIVELY, THE PATIENT PRESENTED WITH A MASS AT THE SURGICAL SITE. THE SITE WAS ASPIRATED. IT IS UNKNOWN IF ANY FURTHER TREATMENT OR INTERVENTION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other