BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163154 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02171
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    March 9, 2018
    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.

    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

    THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR DEGENERATIVE DISEASE AT T11-T12 AND T12-L1 AND UNDERWENT THE FOLLOWING PROCEDURES: 1) LEFT-SIDED THORACOTOMY WITH RETROPLEURAL EXPLORATION OF THE SPINE. 2) SPINAL EXPOSURE OF T11-T12 AND T12-L1. 3) DISCECTOMY, PARTIAL VERTEBRECTOMY AND CAGE INSERTION AT T11-T12 AND T12-L1. 4) ANTERIOR POSTERIOR SPINAL FUSION WITH INSTRUMENTATION, T11 TO L1. AS PER OP-NOTES,¿ ANTERIOR INTERBODY SPINAL FUSION: A SIZE 8 TRIAL WAS DETERMINED TO FIT IN BOTH OF THE T11-12 AND T12-L1 INTERSPACES THAT WERE 40 MM IN LENGTH. WITH THESE TRIALS THUS IN PLACE, AP AND LATERAL FLUOROSCOPIC IMAGES CONFIRMED PROPER PLACEMENT OF THE TRIALS IN BOTH THE AP AND LATERAL PLANES. THE TRIALS WERE THEN REMOVED. THE ACTUAL INTERBODY XLIF SPACER WAS PLACED IN THE INTERVERTEBRAL SPACE ALONG WITH CERAMIC BETA-TRI-CALCIUM PHOSPHATE AND HYDROXYAPATITE. THE XLIF GRAFT WAS PACKED WITH LARGE BMP SPONGES. WITH THE XLIF GRAFTS IN PLACE, AP AND LATERAL FLUOROSCOPIC IMAGES WERE OBTAINED TO CONFIRM PLACEMENT OF THE GRAFTS WHICH WERE CENTERED IN THE MIDLINE ON BOTH THE AP AND LATERAL PLANES. POSTERIOR FUSION WITH INSTRUMENTATION: NEXT, THE SPINOUS PROCESSES OF T11, T12, AND L1 WERE REMOVED. THE INTERSPINOUS LIGAMENTS WERE KEPT INTACT BETWEEN T10 AND T11 TO THE SUPERIOR EDGE OF THE T11 SPINOUS PROCESS WHICH WAS LEFT IN PLACE. THIS BONE, AS WELL AS THE BONE THAT WAS REMOVED FROM THE TRANSVERSE PROCESSES AT THESE LEVELS WITH A RONGEUR, WAS MIXED WITH MORE BMP AND ALSO CANCELLOUS ALLOGRAFT AND ROLLED INTO SPONGES. NEXT, THE LAMINA WAS DECORTICATED AT T11, T12, AND ALSO THE PARS AT L1 WERE DECORTICATED. THIS DECORTICATION WAS DONE WITH AN OSTEOTOME AND A MALLET, AS WELL AS A BUR, DOWN TO BLEEDING BONE. THE BONE GRAFT WAS THEN PLACED. RODS WERE THEN PLACED THROUGH THE SCREW HEADS. LOCKING CAPS WERE PLACED AND TIGHTENED UNDER COMPRESSION. AP AND LATERAL FLUOROSCOPIC IMAGES CONFIRMED PLACEMENT OF THE PEDICLE SCREWS AND RODS UPON COMPLETION OF THE INSTRUMENTATION. AP AND LATERAL FLUOROSCOPIC IMAGES SHOWED ACCEPTABLE PLACEMENT OF THE INSTRUMENTATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263444 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110704AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other