BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8564371 · Received April 30, 2019

    Report

    Report Number
    1030489-2019-00497
    Event Type
    Injury
    Date Received
    April 30, 2019
    Report Date
    April 30, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    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 # 7755124, 510(K)#: K082728 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED 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 HAD UNDERGONE POSTERIOR CERVICAL SPINAL FIXATION AT OC-T1 TO TREAT CERVICAL SPONDYLOTIC MYELOPATHY. ON AN UNKNOWN DATE, POST-OP, THE INTERNAL SHAFT OF THE RIGHT ROD BROKE. THERE WAS A SOUND WHEN THE PATIENT MOVED THE NECK BUT THE PATIENT WAS STILL ABLE TO MOVE HIS NECK, AND THERE WAS NO DECLINE IN HIS QUALITY OF LIFE. A REVISION SURGERY WAS PERFORMED, AND BY PHYSICIAN¿S JUDGMENT, ONLY THE POSTERIOR ROD WAS REMOVED, AND WOUND CLOSURE WAS PERFORMED (WITH THE PLATE AND SCREW STILL REMAINING INSIDE THE PATIENT). NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. ACCORDING TO THE REP, BONE FUSION WAS ALSO NOT ACHIEVED. NO OTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS OF NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358130 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention