BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2874057 · Received December 14, 2012

    Report

    Report Number
    1030489-2012-02822
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 7, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    REPORTEDLY THE PATIENT DEVELOPED "SIGNIFICANT PAIN, HAS CAUSED ME MAJOR NERVE INJURY. IT HAS REQUIRED ME TO SEE A DOCTOR FREQUENTLY SINCE MY SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2005, THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH BURSITIS OVER HARDWARE, STATUS POST REMOTE ADULT SCOLIOSIS, FUSION WITH POSSIBLE PSEUDOARTHROSIS AND UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF HARDWARE, EXPLORATION OF THE FUSION AND RE-INSTRUMENTATION WITH GRAFTING AND RHBMP-2/ACS. THE PATIENT PREOPERATIVE STUDIES REVEALED POSSIBLE PSEUDOARTHROSIS AT T11-T12 AND T7-T8. AS PER THE OP NOTES: ¿THE HOOKS AND SCREWS WERE LEFT AT T12 AND L3 SCREWS IN PLACE. THE PATIENT WAS SOLID AT T11 AND T12 WHICH WAS A SUSPICIOUS AREA IN THE CT SCAN. HOWEVER, A CLEFT WAS FOUND AT T8-T9 AND A CLEFT AT T7-TS. THERE WAS BARELY ANY MOTION THERE, BUT THIS WAS DEFINITE PSEUDOARTHROSES. A CLEFT WAS ALSO FOUND AT T5-T6. THESE AREAS WERE BURROWED UP AND FIBROUS TISSUE WAS THREADED OUT, THE FIBROUS TISSUE BEING CAREFUL NOT TO GET TOO CLOSE TO THE SPINAL CANAL. NEW RODS WERE PLACED INTO THE OLD HOOKS IN ORDER TO SPAN ALL OF THE PSEUDOARTHROSIS CLEFTS. THE T4 HOOKS AND THE MID-THORACIC UPGOING HOOKS WERE USED. THE PEDICLE SCREWS AT T12 WERE EXTREMELY SOLID. ONE OF THESE WAS CHANGED AS IT LINED UP WITH THE NEW ROD BETTER. FOUR POINTS OF FIXATION WAS NEEDED BELOW LOWER PSEUDARTHROSIS SO THE SCREWS AT L3 WAS LEFT AND USED FOR FIXATION POINTS AS WELL SO THERE WAS MULTIPLE SEGMENTAL FIXATION AGAIN. TWO RODS WERE ATTACHED. THE AREAS OVER THE PSEUDARTHROSES WERE BURROWED AND SOME LOCAL BONE GRAFT WAS TAKEN FROM THE LUMBAR AREA WITH ROBUST POSTEROLATERAL FUSION MASS. THEN RHBMP-2/ACS STRIPS WERE PLACED OVER THE NONUNION AREAS AND UTILIZED THE LOCAL BONE GRAFT AS WELL. TWO CROSSLINKS WERE ALSO PLACED. ¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M115008AAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R