BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8777811 · Received July 10, 2019

    Report

    Report Number
    1030489-2019-00734
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 10, 2019
    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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958716, 510K # K042789 AND UPN: (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE PRODUCT NOR THE APPLICABLE IMAGES 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 WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT POSTERIOR FIXATION AT C3-C4. THIS WAS A CASE IN WHICH THE CT NAVIGATION WAS PLANNED TO BE USED; HOWEVER, CT NAVIGATION COULD NOT BE REGISTERED SO THE NAVIGATION COULD NOT BE USED. INTRA-OP, WHEN THE C3-C4 LATERAL MASS SCREW WAS BEING INSERTED WITH THE C-ARM WITHOUT NAVIGATION, IT BROKE. AFTER THAT, BLEEDING OCCURRED WHEN THE SCREW WAS INSERTED AGAIN, SO IT WAS SUSPECTED THAT THE VASCULAR GOT INJURED. HENCE, SCREW FIXATION COULD NOT BE PERFORMED; INSTEAD, THE SPINOUS PROCESS WIRING (ASTRICTION) WAS DONE. THE BROKEN SCREW WAS COMPLETELY REMOVED AND WAS DISCARDED. NO POST-OPERATIVE ADVERSE EVENT HAS BEEN REPORTED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570421 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other