BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9022424 · Received September 13, 2019

    Report

    Report Number
    1030489-2019-01018
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 14, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958716, 510K # K042789 AND UPI: (B)(4) WAS CLEARED IN THE UNITED STATES. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FIXATION AT C3-C6 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OP, WHEN THE SURGEON TRIED TO TIGHTEN THE SET SCREW OF THE SCREW AT RIGHT SIDE OF C6, THE SCREW WAS CUT OUT TO THE LATERAL SIDE; DUE TO WHICH, THE SET SCREW DEVIATED INTO THE MUSCLES. THE SET SCREW WAS FOUND AND RETRIEVED. HENCE, ON THE RIGHT SIDE OF C6, SCREW PLACEMENT WAS GIVEN UP AND SCREW FIXING WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE SURGEON COMMENTED THAT THIS WAS A TECHNICAL ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815482 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5521147

    Patients

    Seq Age Sex Outcome Treatment
    1