BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 2419196 · Received January 10, 2012

    Report

    Report Number
    2246640-2012-00001
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    October 1, 2011
    Report Date
    December 12, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K081227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS FOR THE SUBJECT LOT OF PRODUCT WERE REVIEWED AND INDICATED THAT THE PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL SPECIFICATIONS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE MANUFACTURE OF THE SUBJECT LOT. PLEXUR M PRODUCT LITERATURE LISTS WOUND COMPLICATIONS SUCH "SITE DRAINAGE," AND "EXTRUSION OF PRODUCT WITH OR WITHOUT SIDE EFFECTS," AS POSSIBLE ADVERSE OUTCOMES OF PRODUCT USAGE. THERE HAVE NO ADDITIONAL COMPLAINTS OF THIS NATURE INVOLVING ANY OTHER UNITS MANUFACTURED FROM THIS LOT OF PRODUCT. NO FURTHER ACTION IS REQUIRED. THIS INVESTIGATION IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    PATIENT RECEIVED RESORBABLE BONE VOID FILLER DURING AN OPEN REDUCTION, INTERNAL FIXATION (ORIF) OF THE RIGHT KNEE, RESULTING FROM A SPLIT DEPRESSION OF THE LATERAL TIBIAL PLATEAU WITH SEVERE COMMINUTION OF THE JOINT SURFACE AND EXTREME SUBCHONDRAL CANCELLOUS BONE DEPRESSION. APPROXIMATELY ELEVEN WEEKS POST-OP, THE PATIENT PRESENTED WITH SWELLING AND SITE DRAINAGE WITH REMOVAL OF THE PLATING HARDWARE. MULTIPLE CULTURES WERE NEGATIVE FOR INFECTION. THE GRAFT MATERIAL WAS REPORTEDLY LEFT IN PLACE. APPROXIMATELY FOUR WEEKS LATER THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT BY A REVISION SPECIALIST DUE TO THE LARGE METAPHYSEAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MQV OSTEOTECH, INC. OTSCT0101234

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R