BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 3354480 · Received September 18, 2013

    Report

    Report Number
    2246640-2013-00022
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    August 19, 2013
    Report Date
    August 20, 2013
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE #2 = PLEXUR M, SERIAL # (B)(4), MODEL # 6100-020. (B)(6). (B)(4). THE MANUFACTURING RECORDS FOR THE TWO SUBJECT LOTS OF PRODUCT WERE REVIEWED AND INDICATED THAT THE PRODUCTS WERE MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. THERE HAVE BEEN NO ADDITIONAL REPORTS OF THIS NATURE INVOLVING ANY OTHER UNITS FROM EITHER OF THE TWO SUBJECT LOTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD RESORBABLE BONE VOID FILLER IMPLANTED IN A 'VERY LARGE FEMORAL DEFECT' DURING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE OF THE FEMUR. FIFTEEN MONTHS POST-OP, IT WAS REPORTED THAT "THE FEMUR WAS NOT HEALING," AND A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE GRAFT MATERIAL WAS EXPLANTED AND THE BONE WAS RE-PLATED. IT WAS REPORTED THAT THE SURGEON STATED HE DID NOT FEEL THE GRAFT MATERIAL WAS TO BLAME FOR THE NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470006 PLEXUR M FILLER, BONE VOID, CALCIUM COMPOUND MQV OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) 6100-020

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R