BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3091958 · Received May 3, 2013

    Report

    Report Number
    1030489-2013-01529
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    February 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

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE 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. IMPLANTED DATE: (B)(6) 2003. (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    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 ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM A SPINAL FUSION SURGERY USING RHBMP-2/ACS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ISTHMIC SPONDYLOLISTHESIS, L5-S1 WITH SEVERE SPINAL STENOSIS AND INSTABILITY AND UNDERWENT THE FOLLOWING PROCEDURES: 1) LUMBAR DECOMPRESSION AT L4-5 AND L5-S1 WITH DECOMPRESSION OF THE L5 AND S1 N ERVE ROOTS. 2) POSTERIOR LUMBAR INTERBODY FUSION WITH SHADOW MESH CAGES, 26 X 10 MM, PACKED WITH LOCAL BONE GRAFT, AS WELL AS ANTERIORLY IN THE DISC SPACE PACKING BMP-SOAKED GELFOAM SPONGES. 3) POSTERIOR INSTRUMENTED SPINAL FUSION FROM L5 TO S1 WAS ALSO PERFORMED UTILIZING 3D INSTRUMENTATION, 50 X 7.5 MM SCREWS WERE USED AT L5 AND S1. BICORTICAL PURCHASE WAS OBTAINED AT S1. 4) LOCAL BONE GRAFT FOR AN INTERTRANSVERSE PROCESS FUSION WAS ALSO PERFORMED. AS PER OP-NOTES,¿ A SMALL AMOUNT OF LOCAL BONE GRAFT WAS PLACED ANTERIORLY AROUND THE ANTERIOR ASPECT OF THE ANNULUS AND THEN A PIECE OF GELFOAM SOAKED IN BMP WAS ALSO PLACED ANTERIORLY. ONCE THIS WAS DONE, THE CANCELLOUS LOCAL BONE WAS PACKED INTO THE SHADOW MESH CAGES WHICH WERE THEN PLACED, FIRST ON THE LEFT SIDE. BEFORE PLACING THE RIGHT SIDE, ADDITIONAL LOCAL BONE GRAFT WAS PACKED, AS WELL AS ANOTHER SPONGE INTO THE RIGHT SIDE OF THE DISC SPACE. THE FINAL SHADOW MESH CAGE WAS THEN PLACED. ABUNDANT BONE GRAFT HAD BEEN PACKED INTO THE INTERSPACE.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193760 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