BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM MATRIX PLF

    MDR report key: 3477547 · Received November 19, 2013

    Report

    Report Number
    2246640-2013-00026
    Event Type
    Injury
    Date Received
    November 19, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 30, 2013
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MBP
    PMA / PMN Number
    K051195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE MANUFACTURING RECORDS FOR THE LOT OF PRODUCT WERE REVIEWED, AND INDICATED THAT THE GRAFT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. NO ADDITIONAL REPORTS OF THIS NATURE HAVE BEEN RECEIVED INVOLVING ANY OTHER GRAFTS FROM THE SUBJECT LOT. IT WAS REPORTED THAT THE SURGEON DID NOT SEEM TO THINK THIS INCIDENT WAS DUE TO THE ALLOGRAFT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED ALLOGRAFT BONE VOID FILLER DURING A LUMBAR FUSION (L4 - L5). APPROXIMATELY ONE WEEK LATER, DUE TO "INCREASED BACK AND LEG PAIN" AFTER SURGERY, AND "FLUID COLLECTION (SEROMA) ON MRI," THE PATIENT WAS TAKEN BACK INTO SURGERY FOR I & D. THERE WAS NO REPORT OF INFECTION. AT THE TIME OF THIS REPORT THE PATIENT WAS "DOING GREAT," AND IT WAS REPORTED THAT THE SURGEON DID NOT SEEM TO THINK THIS INCIDENT WAS DUE TO THE ALLOGRAFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599157 GRAFTON DBM MATRIX PLF FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) T42210

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R