BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3505146 · Received December 9, 2013

    Report

    Report Number
    1030489-2013-04967
    Event Type
    Injury
    Date Received
    December 9, 2013
    Report Date
    January 11, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ICBG, SCREWS (IMPLANT (B)(6) 2007, EXPLANT (B)(6) 2010). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING STUDY FILMS 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/USED 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. MULTIPLE MEDWATCH REPORTS HAVE BEEN SUBMITTED FOR THIS PATIENT, REFER TO MANUFACTURER REPORT # 1030489-2013-04966 FOR ADDITIONAL DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE SCOLIOSIS AND SPINAL STENOSIS. THE PATIENT UNDERWENT FUSION SURGERY USING RHBMP-2/ACS, ILIAC CREST BONE GRAFT (ICBG) AND PEDICLE SCREW INSTRUMENTATION. DURING THE SURGERY, THE PEDICLE SCREW INSTRUMENTATION WAS COMPLETED BY PLACING RODS ON THE POLYAXIAL HEADS OF THE PEDICLE SCREWS AND SECURING THEM USING CAP SCREWS. THE ILIAC CREST AUTOGRAFT AND BMP COMPOSITE WAS PACKED OVER THE DECORTICATED POSTERIOR ELEMENTS IN ORDER TO COMPLETE A POSTEROLATERAL ARTHRODESIS FROM L1 TO L4. REPORTEDLY, THE PATIENT¿S "POST-OPERATIVE PERIODS WERE MARKED BY COMPLICATIONS WHICH INCLUDED, BUT WERE NOT LIMITED TO, THE NEED FOR ADDITIONAL SURGERY, PAINFUL MEDICAL TREATMENT, EXTREME PAIN, NERVE DAMAGE, NERVE IMPINGEMENT, AND ECTOPIC BONE FORMATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007, THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF DEGENERATIVE SCOLIOSIS AND SPINAL STENOSIS AND UNDERWENT FOLLOWING PROCEDURE : (1) POSTERIOR SPINAL FUSION, L1 TO L4. (2) PEDICLE SCREW INSTRUMENTATION, L1 TO L4. (3) RIGHT ILIAC CREST BONE GRAFT. PER OP NOTES, "... THE SURGEON DECORTICATED THE TRANSVERSE PROCESSES OF L 1, L2, L3 AND L4 BILATERALLY. TWO LARGE RHBMP-2 KITS WERE PREPARED ACCORDING TO MANUFACTURES INSTRUCTIONS. RECONSTITUTED BNP AND SOAKED FOR GREATER THAN 15 MINUTES. THE RHBMP-2 SPONGES WERE CUT TRANSVERSELY. THE ILIAC CREST AUTOGRAFT WAS PACKED IN THE CENTER AND THE RHBMP-2 SPONGES WERE TRIMMED AND SEWN ONTO THEMSELVES INTO A TUBE. THE ILIAC CREST AUTOGRAFT AND RHBMP-2 COMPOSITE WAS PACKED OVER THE DECORTICATED POSTERIOR ELEMENTS IN ORDER TO COMPLETE A POSTEROLATERAL ARTHRODESIS FROM L1 TO L4. "(B)(6) 2010 , THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF ADJACENT LEVEL SPINAL STENOSIS T12-L1 , T11-T12 ABOVE A PRIOR L1-L4 FUSION. THE PATIENT UNDERWENT FOLLOWING PROCEDURES : (1) HARDWARE REMOVAL AND EXPLORATION OF FUSION AT L 1-L3. (2) POSTERIOR SPINAL FUSION T10-L1. (3) REVISION AND INSTRUMENTATION T10-L2. (4) LOCAL BONE GRAFT. PER OP NOTES,"... SIX 5 X 40 SCREWS WERE PLACED INTO THE OLD HOLES AT L 1 AND L2 BILATERALLY. WE THEN PLACED NEW SCREWS AT 0, T11, AND T12 BILATERALLY. A LARGE BMP KIT WAS PREPARED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS, RECONSTITUTED WITH BMP AND SOAKED FOR GREATER THAN 15 MINUTES. IT WAS CUT INTO STRIPS AND LAID OVER THE DECORTICATED POSTERIOR ELEMENTS . LOCAL BONE OBTAINED FROM THE LAMINECTOMY WAS MORSEIIZED THROUGH A BONE MM AND PACKED DORSAL TO THIS ALONG WITH 20 CUBIC CENTIMETERS OF BONE GRAFT MATRIX.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637126 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other