BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 12370756 · Received August 26, 2021

    Report

    Report Number
    1030489-2021-01090
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    January 7, 2021
    Report Date
    August 26, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CHRISTOPH SCHOLZ., JAN-HELGE KLINGLER., WASEEM MASALHA., MARC HOHENHAUS., FLORIAN VOLZ., IOANNIS VASILIKOS., ROLAND ROELZ., CHRISTIAN SCHEIWE., ULRICH HUBBE. ¿LONG-TERM RESULTS AFTER MULTILEVEL FUSION OF THE CERVICAL SPINE AND THE CERVICOTHORACIC JUNCTION: TO BRIDGE OR NOT TO BRIDGE?¿ WORLD NEUROSURG. (2021) 148:E556-E564. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.01.025 OBJECTIVE: FOR PATIENTS WITH MULTILEVEL DEGENERATIVE CERVICAL MYELOPATHY, LAMINECTOMY AND FUSION ARE WIDELY ACCEPTED TECHNIQUES FOR AMELIORATING THE DISORDER. HOWEVER, THE IDEA OF WHETHER ONE SHOULD BRIDGE THE CERVICOTHORACIC JUNCTION TO PREVENT INSTRUMENT FAILURE OR ADJACENT SEGMENT DISEASE HAS BEEN A SUBJECT OF CONTROVERSIAL DISCUSSION. IN THE PRESENT STUDY, WE COMPARED THE INCIDENCE OF THESE COMPLICATIONS AND THE REVISION RATES IN MULTILEVEL FUSIONS EXTENDING TO C7 OR T1ET3. METHODS: IN THE PRESENT SINGLE-CENTER, RETROSPECTIVE COHORT STUDY, PATIENTS WITH MULTILEVEL DEGENERATIVE CERVICAL MYELOPATHY TREATED WITH LAMINECTOMY AND FUSION TO C7 OR T1-T3 FROM 2004 TO 2016 WERE INCLUDED FOR EVALUATION. THE PRIMARY OUTCOME MEASURE WAS RADIOLOGICALLY PROVEN COMPLICATIONS AT THE MOST CAUDAL LEVEL OR THE ADJACENT SPINAL FUSION LEVEL. REPORTED EVENTS: THE FOLLOWING SYSTEMS FOR FUSION WERE USED: NEON SYSTEM, 40 TIMES, AND NEON3 SYSTEM, 13 TIMES (BOTH ULRICH MEDICAL, ULM, GERMANY); VERTEX SELECT, 3 TIMES (MEDTRONIC, MINNEAPOLIS, MINNESOTA, USA); AND OASYS, 2 TIMES (STRYKER, KALAMAZOO, MICHIGAN, USA). SCREW BREAKAGE OCCURRED 7 TIMES WITH THE NEON AND 1 TIME EACH WITH THE NEON3 AND THE VERTEX SELECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266560 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. MSB_UNK_SCRW_VTX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1