BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXUR M

    MDR report key: 2034684 · Received March 17, 2011

    Report

    Report Number
    2246640-2011-00009
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 21, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO ON THIS FORM 3500A WAS COMPLETED USING THE INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT BEING PROVIDED BY THE REPORTER. OSTEOTECH'S ATTEMPTS TO OBTAIN ADD'L INFO FROM THE REPORTER HAVE BEEN UNSUCCESSFUL. ALL MFG RECORDS FOR THE SUBJECT UNIT OF PLEXUR M WERE REVIEWED, AND INDICATED THAT THE PRODUCT WAS MFG ACCORDING TO PROCEDURE AND MET ALL SPECS. ALL CRITICAL PROCESSING PARAMETERS WERE MET, AND THERE WERE NO IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THE PRODUCT. THE SUBJECT UNIT OF PLEXUR M WAS TERMINALLY STERILIZED USING GAMMA IRRADIATION, WITHIN THE REQUIRED DOSAGE RATE, AND WAS RELEASED STERILE, AS LABELED. THERE HAVE BEEN NO ADD'L REPORTS OF THIS NATURE INVOLVING PRODUCT MFR FROM THIS DONOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON (B)(6) 2010, THE SURGEON PLACED THE RESORBABLE BONE VOID FILLER TO FILL A NON-UNION OF THE DISTAL TIBIA. THE GRAFTING MATERIAL WAS PLACED OVER THE FRACTURE SITE, BASICALLY SUBCUTANEOUSLY. AT 6 MONTHS POST-OP, THE X-RAY SHOWED THAT THE FRACTURE WAS UNITED. SURGEON WAS CONCERNED WITH A FLUCTUANT MASS AT THE OPERATIVE SITE, WHICH THE PT FIRST NOTED TO HAVE BEEN FIRM AND HARD AND HAD NO SOFTENED. THE PT DID NOT REPORT ANY PAIN; THERE WERE NO SIGNS OF INFECTION, NOR ANY TENDERNESS OF THE AREA. THE SURGEON STATED HE DID NOT WISH TO ASPIRATE THE AREA FOR FEAR OF INTRODUCING INFECTION. THE PT IS REPORTEDLY DOING WELL AND NO ADD'L MEDICAL OR SURGICAL INTERVENTIONS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MQV OSTEOTECH, INC. 5CC OTSCT0101047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other