BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 5077021 · Received September 15, 2015

    Report

    Report Number
    1030489-2015-02361
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 23, 2015
    Report Date
    August 23, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958716, 510K # K081297 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED. HENCE, IT IS DIFFICULT TO DRAW ANY CONCLUSION AS OF NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT CERVICAL POSTERIOR FUSION FOR TRAUMA. DURING THE SURGERY, A LATERAL MASS ON THE RIGHT C5 WAS CRACKED JUST WHEN A SCREW WAS INSERTED. THE SCREW WAS REMOVED. THE SURGERY WAS COMPLETED WITHOUT INSERTING C5 SCREW. NO SURGICAL TIME WAS EXTENDED BY THIS EVENT. FRACTURE DISLOCATION OCCURED AT C6. SPINAL FUSION WAS CONDUCTED AT C4-TH1 (RIGHT C5 WAS SKIPPED).IT IS NOT CERTAIN WHETHER THE LATERAL MASS GOT BROKEN DUE TO THE PATIENT'S BONE QUALITY OR INSERTION TRAJECTORY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609284 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other