BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3200946 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02860
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    December 1, 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

    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) 2009 THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH DEGENERATIVE DISK DISEASE, L4-5 AND L5-S1, WITH NEURAL FORAMINAL SPINAL STENOSIS, L5-S1; STATUS POST DISCECTOMY, LEFT L4-5 X2 AND DISCECTOMY, LEFT L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: TRANSFORAMINAL INTERBODY FUSION, L4-5. TRANSFORAMINAL INTERBODY FUSION, L5-S1. INSERTION OF INTERVERTEBRAL CAGE DEVICE, L4-5. INSERTION OF INTERVERTEBRAL CAGE DEVICE, L5-S1. POSTEROLATERAL SPINAL FUSION, L4-5. POSTEROLATERAL SPINAL FUSION, L5-S1. POSTERIOR SEGMENTAL PEDICLE INSTRUMENTATION, L4-5, L5-S1. ILIAC CREST AUTOGRAFT THROUGH A SEPARATE FASCIAL INCISION. X-RAY PRIOR TO SURGERY REVEALED THAT LEFT L4-5 AND L5-S1 HEMILAMINOTOMY DEFECTS AND MARKED DEGENERATIVE DISK DISEASE, L5-S1 WITH FORAMINAL NARROWING. THERE WAS MODERATE DISK SPACE NARROWING AT L4-5. POST-OP MRI REVEALED CHANGE ON THE LEFT AT L4-5 AND L5-S1. THERE WAS MARKED DEGENERATIVE DISK DISEASE, L5-S1, AND MODERATE AT L4-5. THERE APPEARED TO BE FORAMINAL STENOSIS ON THE RIGHT AT L5-S1, DUE TO DISK SPACE COLLAPSE. AS PER THE OP NOTES:¿ THE INTERBODY FUSION WAS PERFORMED BY CREATING AN ANNULOTOMY WITH A 15 BLADE SCALPEL ON THE RIGHT-SIDED D ISK AT L4-5. MULTIPLE SIZED PITUITARY RONGEURS, CURETTES, AND SCRAPERS WERE USED TO PERFORM A THOROUGH DISCECTOMY, INCLUDING THE CARTILAGINOUS ENDPLATES. VARIOUS TRIAL IMPLANTS WERE INSERTED FROM THE STRYKER ABF PEEK SYSTEM. A DECISION WAS MADE TO USE A 12-MM STRUCTURAL INTERVERTEBRAL CAGE. RHBMP-2/ACS WAS PREPARED IN THE COLLAGEN CARRIER. THE RHBMP-2/ACS WAS PLACED WITHIN THE CAGE. THE 12-AM CAGE WAS INSERTED INTO THE EVACUATED DISK AT L4-5, AND COUNTERSUNK 3 TO 4 MM FROM THE POSTERIOR VERTEBRAL BODY MARGINS. THE CAGE WAS FILLED WITH RHBMP-2/CS AND A COLLAGEN CARRIER IN A ROUTINE FASHION. THE 10 MM CAGE WAS INSERTED INTO THE EVACUATED DISK AT L5-S1, FOR THE INTERBODY FUSION.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303402 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