BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3970516 · Received July 31, 2014

    Report

    Report Number
    1030489-2014-03375
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(96) 2004 THE PATIENT PRESENTED WITH PRE-OP DIAGNOSES OF CERVICAL SPONDYLITIC MYELOPATHY AND RADICULOPATHY. THE PATIENT UNDERWENT ANTERIOR POSTERIOR PARTIAL VERTEBRECTOMY C3, C4,; C5 AND C6, COMPLETE DISCECTOMY C3-C4, C4-C5, C5-C6, INTERBODY FUSION USING IMPLANT WITH BMP AND LOCAL BONE SOURCE, USING ANTERIOR PLATE AT C3-C6, SELECTIVE MICRO-DISSECTION TECHNIQUE, INTRAOPERATIVE FLUOROSCOPY. PER OP NOTES, ANTERIOR OSTEOPHYTES FROM C3-C4 DOWN TO C5-C6 WERE REMOVED. THUS, COMPLETE DISCECTOMY WAS CARRIED OUT. THEN USING INTRAOPERATIVE MAGNIFICATION MICROSCOPE, INTRAOPERATIVE FLUOROSCOPY, AND HIGH-SPEED DRILL, PARTIAL VERTEBRECTOMIES WERE PERFORMED ON EITHER SIDE OF EACH DISC SPACE. AFTER COMPLETE REMOVAL OF POSTERIOR LONGITUDINAL LIGAMENT, POSTERIOR DISK SPACE, AND FORAMINOTOMIES, DISTRACTION PINS WERE THEN PLACED. APPROPRIATE HYDRASORB RING WAS THEN CHOSEN, PACKED WITH BMP AND LOCAL BONE SOURCE, COUNTERSUNK ONE MILLIMETER. PINS WARE THEN REMOVED AND THE PIN HOLE SITES WERE PACKED WITH GELFOAM. APPROPRIATE PLATE WAS CHOSEN, CONTOURED TO THE SPINE, SECURED BY DRILLING AND USING 15- AND 14-RNM SCREWS, LOCKING NUTS IN THE USUAL FASHION. WOUNDS WERE THEN CLOSED IN USUAL STERILE FASHION. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2004 THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447559 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M112003ABB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other