BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6903202 · Received September 29, 2017

    Report

    Report Number
    1030489-2017-02133
    Event Type
    Injury
    Date Received
    September 29, 2017
    Report Date
    September 8, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 6958720, 510K# K143471 AND (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION AT C1/2 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. REPORTEDLY, AFTER THE OPERATION, C2 SCREWS IN THE BOTH SIDE BECAME LOOSE, BUT IT WAS NOT BACK-OUT. IT WAS UNKNOWN WHETHER THE PATIENT HAD ACHIEVED SOLID FUSION OR NOT. THERE WAS NO PARTICULAR SYMPTOM, BUT THE PATIENT WAS RE-HOSPITALIZED DUE TO RE-OPERATION. IN RE-OPERATION, SCREWS IN C2 WERE REMOVED, SCREWS WERE INSERTED INTO C3/4 AND IT WAS CONNECTED TO C1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684458 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5282456

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention