BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4923009 · Received July 17, 2015

    Report

    Report Number
    1030489-2015-01497
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    January 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION : NANCY E. EPSTEIN. "PRELIMINARY DOCUMENTATION OF THE COMPARABLE EFFICACY OF VITOSS VERSUS NANOSS BIOACTIVE AS BONE GRAFT EXPANDERS FOR POSTERIOR CERVICAL FUSION." (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) IN A LITERATURE ARTICLE TITLED PRELIMINARY DOCUMENTATION OF THE COMPARABLE EFFICACY OF VITOSS VERSUS NANOSS BIOACTIVE AS BONE GRAFT EXPANDERS FOR POSTERIOR CERVICAL FUSION WAS REVIEWED FOR TWO SUCCESSIVE PROSPECTIVE COHORTS OF PATIENTS UNDERWENT 1-3 LEVEL LAMINECTOMIES WITH 5-9 LEVEL POSTERIOR CERVICAL FUSIONS TO ADDRESS CERVICAL SPONDYLOTIC MYELOPATHY (CSM) AND/OR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL). THE FIRST COHORT OF 72 PATIENTS RECEIVED VITOSS, WHILE THE SECOND COHORT OR 20 PATIENTS RECEIVED NANOSS. FUSIONS WERE PERFORMED UTILIZING THE ROD/EYELET SYSTEM WITH BRAIDED TITANIUM CABLES THROUGH THE BASE OF INTACT SPINOUS PROCESSES (NOT LATERAL MASS SCREWS) CEPHALAD AND CAUDAD TO LAMINECTOMY DEFECTS. THE AVERAGE AGES WERE, RESPECTIVELY, 63.3 (VITOSS) AND 62.5 (NANOSS). ONE TO THREE LEVEL LAMINECTOMIES (E.G. INCLUDING BILATERAL MEDIAL FACETECTOMY/FORAMINOTOMIES) WERE PERFORMED UNDER AN OPERATING MICROSCOPE UTILIZING DIAMOND DRILLS AND SMALL 1-2 MM KERRISON RONGEURS TO REMOVE LATERAL BONE. THIS WAS FOLLOWED BY 5-9 LEVEL (E.G. TYPICAL C2-T2) ROD/EYELET FUSIONS PERFORMED UTILIZING BRADED TITANIUM CABLES (NO LATERAL MASS SCREWS) PASSED THROUGH THE BASE OF INTACT CEPHALAD/CAUDAD SPINOUS PROCESSES. PSEUDARTHROSIS WAS OBSERVED IN 2 (2.8%) OF VITOSS PATIENTS WHO DEVELOPED EARLY DEEP WOUND INFECTIONS RESULTING IN GRAFT RESORPTION; BOTH REQUIRED OPERATIVE DEBRIDEMENT WITHIN A MONTH OF THE ORIGINAL SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY NANCY E. EPSTEIN IN A LITERATURE ARTICLE TITLED PRELIMINARY DOCUMENTATION OF THE COMPARABLE EFFICACY OF VITOSS VERSUS NANOSS BIOACTIVE AS BONE GRAFT EXPANDERS FOR POSTERIOR CERVICAL FUSION WAS REVIEWED FOR TWO SUCCESSIVE PROSPECTIVE COHORTS OF PATIENTS UNDERWENT 1-3 LEVEL LAMINECTOMIES WITH 5-9 LEVEL POSTERIOR CERVICAL FUSIONS TO ADDRESS CERVICAL SPONDYLOTIC MYELOPATHY (CSM) AND/OR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL). THE FIRST COHORT OF 72 PATIENTS RECEIVED VITOSS, WHILE THE SECOND COHORT OR 20 PATIENTS RECEIVED NANOSS. FUSIONS WERE PERFORMED UTILIZING THE ROD/EYELET SYSTEM WITH BRAIDED TITANIUM CABLES THROUGH THE BASE OF INTACT SPINOUS PROCESSES (NOT LATERAL MASS SCREWS) CEPHALAD AND CAUDAD TO LAMINECTOMY DEFECTS. THE AVERAGE AGES WERE, RESPECTIVELY, 63.3 (VITOSS) AND 62.5 (NANOSS). ONE TO THREE LEVEL LAMINECTOMIES (E.G. INCLUDING BILATERAL MEDIAL FACETECTOMY/FORAMINOTOMIES) WERE PERFORMED UNDER AN OPERATING MICROSCOPE UTILIZING DIAMOND DRILLS AND SMALL 1¿2 MM KERRISON RONGEURS TO REMOVE LATERAL BONE. THIS WAS FOLLOWED BY 5-9 LEVEL (E.G. TYPICAL C2-T2) ROD/EYELET FUSIONS PERFORMED UTILIZING BRADED TITANIUM CABLES (NO LATERAL MASS SCREWS) PASSED THROUGH THE BASE OF INTACT CEPHALAD/CAUDAD SPINOUS PROCESSES. PSEUDARTHROSIS WAS OBSERVED IN 2 (2.8%) OF VITOSS PATIENTS WHO DEVELOPED EARLY DEEP WOUND INFECTIONS RESULTING IN GRAFT RESORPTION; BOTH REQUIRED OPERATIVE DEBRIDEMENT WITHIN A MONTH OF THE ORIGINAL SURGERY. ONE PATIENT WHO RECEIVED VITOSS DEVELOPED A STERILE SEROMA 3 WEEKS POSTOPERATIVELY AND REQUIRED DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465786 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other