BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6992572 · Received November 1, 2017

    Report

    Report Number
    1030489-2017-02274
    Event Type
    Injury
    Date Received
    November 1, 2017
    Report Date
    December 7, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 7755124, 510K # K082728 AND UDI (B)(4) IS APPROVED FOR SALE IN US. THE DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 UNDERWENT POSTERIOR SPINAL FUSION AT O-T2 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. POST OPERATIVELY, THE ADJUSTABLE PART OF THE ROD WAS LOOSENED AND WAS MOVING. REPORTEDLY, ROD WILL BE REINSERTED AT A LATER DATE. THE FINAL TIGHTENING WAS DONE PROPERLY DURING THE INITIAL SURGERY. RE-TIGHTENING OF THE ROD IS THOUGHT NOT TO WORK BECAUSE OF SKIP VERTEBRAL BODIES AND INSTABILITY OF ANTERIOR ELEMENTS. IN RE-OPERATION, ANTERIOR FIXATION WILL BE ADDED USING PRE-BENT ROD.

    Description of Event or Problem · 1

    SINCE THE PATIENT HAD NO SYMPTOMS, NO REVISION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771882 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0546975W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention