BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 3496919 · Received December 3, 2013

    Report

    Report Number
    2246640-2013-00027
    Event Type
    Injury
    Date Received
    December 3, 2013
    Date of Event
    November 10, 2013
    Report Date
    November 13, 2013
    Manufacturer
    OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE #2 - PLEXUR M - MODEL 6100-010, SERIAL # (B)(4), SUSPECT DEVICE #3 - PLEXUR, M - MODEL 6100-010, SERIAL # (B)(4), IT IS NOT POSSIBLE TO DETERMINE WHICH SUSPECT DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. (B)(6). (B)(4). REVIEW OF THE RELEVANT DEVICE HISTORY RECORDS INDICATED THAT THE DEVICES WERE MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATION AND RELEASE CRITERIA.

    Description of Event or Problem · 1

    HCP REPORTED THAT HE IMPLANTED RESORBABLE BONE VOID FILLER IN A PATIENT¿S ¿PERIACETABULAR LESION,¿ AND APPROXIMATELY 11 WEEKS POST-OP, THE PATIENT DEVELOPED SOFT TISSUE SWELLING, FLUID COLLECTION AT THE IMPLANT SITE, WITH "POSSIBLE EXTRUSION OF THE GRAFT MATERIAL." THE WOUND WAS 'CLEANED' AND CULTURES WERE TAKEN. CULTURES WERE NEGATIVE FOR THE PRESENCE OF INFECTION. PATIENT WAS PLACED ON ANTIBIOTICS, IS REPORTEDLY ¿PAIN-FREE¿ AND ¿BEING OBSERVED.¿ NO REVISION SURGERY WAS PERFORMED AND THE GRAFT MATERIAL WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624825 PLEXUR M FILLER, BONE VOID, CALCIUM COMPOUND MQV OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC) 6100-010

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention