BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTAPEK VBR CAGE

    MDR report key: 9098077 · Received September 19, 2019

    Report

    Report Number
    MW5089921
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    March 15, 2019
    Report Date
    September 18, 2019
    Manufacturer
    COLIGNE AG
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LITERATURE CAWLEY, DEREK T., ET AL., "CARBON-FIBRE CAGE RECONSTRUCTION IN ANTERIOR CERVICAL CORPECTOMY FOR MULTILEVEL CERVICAL SPONDYLOSIS: MID-TERM OUTCOMES" JOURNAL OF SPINE SURGERY 5.2 (2019): 251 REPORTS USE OF OSTAPEK POLYCARBON-FIBER VBR CAGE (COLIGNE AG) IN 17-63MM LENGTHS FOR SINGLE AND MULTILEVEL CERVICAL CORPECTOMY RESULTED IN 20 CASES OF SUBSIDENCE (28.6%), 9 SEVERE SUBSIDENCE (13%), ONE PT HAD A MALPOSITIONED CAGE REQUIRING REVISION WITHIN 24 HOURS. ONE CAGE MIGRATION PROGRESSED OVER 6 WEEKS TO ULTIMATELY REQUIRE REVISION. ONE PT HAD A POSTERIORLY MALPLACED CAGE REQUIRING A POSTERIOR LAMINECTOMY AT SIX WEEKS. OSTAPEK CAGE [K072328] DESIGNATED NON-CERVICAL INDICATION (MQP), DEVICE-USE FOR CERVICAL INDICATIONS NOT FDA-APPROVED. CONSTRUCT LENGTHS OF 63MM INTENDED FOR NON-FDA APPROVED MULTILEVEL CERVICAL VERTEBRAL BODY REPLACEMENT. STUDY FAILS TO DISCLOSE USE OF DEVICE FOR CERVICAL INDICATIONS ARE NOT FDA-APPROVED. DEVICE DESIGN RATIONALE AND INSTRUMENTS REQUIRED TO IMPLANT THE DEVICE CONFIGURED FOR ANTERIOR CERVICAL SPINE USE, YET LABELING DIRECTS USE IN THE THORACOLUMBAR SPINE. LABELING IS NOT CONSISTENT WITH DESIGN RATIONALE, OBJECTIVE INTENT AND MANNER IN WHICH DEVICE IS ACTUALLY PUT TO USE AND SOLD FOR IN THE UNITED STATES. FIGURE 2 SHOWS CAGE DISLOCATION WHEN USED FOR MULTILEVEL CERVICAL VERTEBRAL BODY REPLACEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889652 OSTAPEK VBR CAGE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP COLIGNE AG

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R