BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 5401139 · Received February 1, 2016

    Report

    Report Number
    1030489-2016-00339
    Event Type
    Injury
    Date Received
    February 1, 2016
    Report Date
    March 7, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL, OPTICAL AND FUNCTIONAL EVALUATION CONFIRM SET SCREW THREADS ARE UNDAMAGED. SET SCREW ROD INTERFACE NODE MORPHOLOGY IS FOUND TO BE TROUGHED, WHICH IS TYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) CONSISTENT WITH BENCH SAMPLES. CONCLUSION: SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS CONSISTENT WITH FULL SEATING OF THE SET SCREW AT FINAL TIGHTENING.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6950315, 510K # K042498 WAS CLEARED IN THE UNITED STATES. IMAGE REVIEW OF THE PRODUCT: ADDITIONAL INFORMATION CONCERNING INSTRUMENT COMPLAINT UNABLE TO BE OBTAINED FROM SUBMITTED IMAGES. THE PRODUCT HAS BEEN RETURNED , THE EVALUATION IS YET TO BEGIN. HENCE, IT IS DIFFICULT TO DRAW ANY CONCLUSIONS AS OF NOW.

    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 CERVICAL POSTERIOR FUSION AT OCCIPITAL-CERVICAL2. ON AN UNKNOWN DATE, POST-OP, THE PATIENT COMPLAINED OF SOME NOISE FROM THE SURGICAL SITE. SCREW MIGRATION WAS OBSERVED BY X-RAY SO REVISION SURGERY WAS PERFORMED . NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61062 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5194146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention