BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3127346 · Received May 23, 2013

    Report

    Report Number
    1030489-2013-01873
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    October 27, 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)(6). (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.

    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

    IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT WAS POST-OPERATIVELY DIAGNOSED WITH LUMBAR SPONDYLOSIS, L4-5 HERNIATED DISC, RADICULOPATHY AND THE FOLLOWING PROSTHETIC DEVICES WERE IMPLANTED: 5.5MM SYSTEM, PEEK CAGE, BONE MORPHOGENIC PROTEIN (RHBMP-2/ACS), MORSELIZED ALLOGRAFT. AS PER OP-NOTES, ¿LARGE FRAGMENTS OF EXTRUDED DISC WERE DISSECTED OUT AND REMOVED. FOLLOWING REMOVAL OF THIS FRAGMENT, WE VISUALIZE SIGNIFICANT DECOMPRESSION OF THE L5 AND S1 NERVE ROOTS WITH RELAXATION OF THE LEFT L5 NERVE ROOT. WE THEN IDENTIFIED THE L4-5 DISC SPACE JUST ABOVE THE L5 PEDICLE. THIS DISC WAS EXCISED USING 15 BLADE FOLLOWING GENTLE RETRACTION OF THE THECAL SAC. THIS WAS REMOVED USING PITUITARY RONGEURS AND DISC SHAVERS AS COMPLETELY AS POSSIBLE. WE THEN ALSO PERFORMED A LEFT-SIDED COMPLETE FACETECTOMY AT LS-S1 WITH A PARTIAL LEFT HEMILAMINECTOMY. FOLLOWING REMOVAL OF LIGAMENTUM FLAVUM IN A PIECEMEAL FASHION, WE WERE ABLE TO IDENTIFY THE L5 AND THE S1 NERVE ROOTS NEAR THE REGION OF THE L5-S1 FORAMINA. THE L5-S1 DISC SPACE WAS IDENTIFIED OVER THE LEFT S1 PEDICLE. THIS DISC WAS EXCISED USING A 15 BLADE FOLLOWING A SLIGHT MEDIAL RETRACTION OF THE THECAL SAC USING A NERVE ROOT RETRACTOR. THE DISKECTOMY WAS PERFORMED USING PITUITARY RONGEURS AND DISC SHAVERS.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227932 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other