BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 1947336 · Received December 29, 2010

    Report

    Report Number
    2246640-2010-00005
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT SURGICAL PROCEDURE INVOLVED IMPLANTATION OF THE FOLLOWING 3 UNITS OF PLEXUR M: MODEL #20CC - CATALOG #6100-020 - (B)(4), MODEL #10CC - CATALOG #6100-010 - (B)(4), MODEL #10CC - CATALOG #6100-010 - (B)(4). ALL MFG RECORDS FOR THE THREE SUBJECT LOTS OF PLEXUR M WERE REVIEWED, AND INDICATED THAT THE GRAFTS WERE MANUFACTURED ACCORDING TO THE PROCEDURE AND MET ALL SPECIFICATIONS. ALL CRITICAL PROCESSING PARAMETERS WERE MET AND THERE WERE NO IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THE GRAFTS. THE SUBJECT LOTS OF PLEXUR M WERE TERMINALLY STERILIZED WITH GAMA IRRADIATION WITHIN THE REQUIRED DOSAGE RATE. A LIST OF DETAILED QUESTIONS HAS BEEN FORWARDED TO THE SURGEON FOR F/U, AND OSTEOTECH'S (B)(4) WILL BE CONTACTING THE SURGEON DIRECTLY IN AN EFFORT TO OBTAIN FURTHER INFO. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    SURGEON STATES THAT WHILE REVISING A PREVIOUS "DIFFICULT" HIP REVISION IN WHICH HE HAD IMPLANTED PLEXUR M, HE OBSERVED NO BONE FORMATION IN THE GRAFTED AREA AND THE REMNANTS OF THE PRODUCT WERE "LIKE OAT MEAL." NO ADDITIONAL DETAILS WERE PROVIDED. OSTEOTECH CONTACTED THE SURGEON'S PA ON (B)(6) 2010, BUT THE PA WAS UNABLE TO PROVIDE ANY ADDITIONAL INFO AND INDICATED THAT THE SURGEON WAS OUT OF TOWN AT THE TIME. SEVERAL SUBSEQUENT ATTEMPTS TO OBTAIN INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MQV OSTEOTECH, INC. 20CC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R