BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191368 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02550
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 UNDERWENT AN L3-S1 FUSION UTILIZING A POSTEROLATERAL APPROACH WITH RHBMP-2/ACS AT MULTIPLE LEVELS WITH PEEK CAGES, AS WELL AS BY MIXING THE RHBMP-2/ACS WITH ALLOGRAFT AND AUTOGRAFT. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH INJURIES INCLUDING, BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO BMP, CHRONIC PAIN, AND ADDITIONAL SURGERIES. AS A RESULT, THE PATIENT REQUIRED EXTENSIVE MEDICAL TREATMENT, INCLUDING BUT NOT LIMITED TO HAVING TO UNDERGO AN ADDITIONAL SURGERY ON (B)(6) 2007. THE PATIENT REPORTEDLY HAS NEVER RECOVERED FROM HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR AND POSTEROLATERAL LUMBAR INTERBODY FUSION AT L3-S1 USING RHBMP-2/ACS. POST-OPERATIVELY, PATIENT WAS DIAGNOSED WITH NERVE DAMAGE AND A CYST AT THE SITE OF THE FUSION. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: SPONDYLOLISTHESIS WITH SPINAL STENOSIS. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: L3 AND L4 LAMINECTOMIES WITH FORAMINOTOMIES, PARTIAL MEDIAL FACETECTOMY ON LEFT AND COMPLETE INFERIOR FACETECTOMY ON RIGHT. L5 LAMINECTOMIES WITH FORAMINOTOMIES AND COMPLETE INFERIOR FACETECTOMY ON LEFT. TRANSFORAMINAL LUMBAR INTERBODY FUSION L3-4, L4-5, L5-S1. PEEK INTERBODY FUSION CAGE L3-4, L4-5, L5-S1. POSTERIOR SPINAL FUSION L3-4, L4-5 AND L5-S1. POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION L3 THROUGH S1 WITH SHORT POST SCREW/ROD CONSTRUCT. MORCELLIZED AUTOGRAFT AND ALLOGRAFT BONE GRAFT. BMP SPONGE PREPARATION AND APPLICATION. AS PER-OP NOTES: DISSECTION WAS CARRIED DOWN TO L3, L4 AND L5 SEGMENTS. ON THE RIGHT SIDE, THE INFERIOR FACET AT L4 AND ON LEFT SIDE INFERIOR FACET AT L5 WAS RESECTED. TRANSFORAMINAL APPROACHES TO L3-4, L4-5 AND L5-S1 INTERSPACES WERE PERFORMED. COMPLETE DISKECTOMY WAS THEN CARRIED OUT AT THESE 3 LEVELS. END PLATES WERE PREPARED FOR FUSION WITH CURETTES. RHBMP-2 WAS MIXED AND 3 SPONGES WERE PLACED INTO EACH OF THE INTERSPACES AT L3-4, L4-5 AND L5-S1. THESE SPONGES WERE ROLLED OVER, MORCELLIZED TO AUTOGRAFT PRODUCTS AT DECOMPRESSION. AFTER PERFORMING COMPLETE DECOMPRESSION THE PEEK INTERBODY FUSION CAGES WERE FILLED WITH MORCELLIZED AUTOGRAFT BONE AND WERE IMPACTED INTO INTERSPACE AT L3-4, L4-5 AND L5-S1. SCREWS WERE PLACED INTO VERTEBRAL BODIES BILATERALLY AT L3, L4, L5 AND S1. REMAINING BMP SPONGE WAS PLACED ON THE LEFT POSTEROLATERALY AT L3-4 AND REMAINING BONE GRAFT WAS PLACED POSTEROLATERALY FOR ARTHRODESIS AT L3-4, L4-5 AND L5-S1. ON (B)(6) 2007: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: RIGHT L3-4 SEROMA AND RADICULOPATHY WITH RETAINED SPINAL INSTRUMENTATION. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: FUSION EXPLORATION, RIGHT L3-4. RIGHT L3-4 FORAMINOTOMY. IRRIGATION AND DEBRIDEMENT OF SEROMA, SPINE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291436 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 51 YR Required Intervention