BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4131580 · Received October 1, 2014

    Report

    Report Number
    1030489-2014-03777
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 3, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K082728
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS : VISUALLY CONFIRMED THAT THE NO MATERIAL DEFORMATION, CRACK, FRACTURE OR BREAKAGE IS NOTED. AFTER VISUAL REVIEW, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OF THE IMPLANT, AND APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION. THE DIFFICULTY IN REMOVAL IS DUE TO THE BROKEN CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION AT C1-2. IT WAS REPORTED THAT THE EXTENSION CONNECTOR SET SCREW BROKE OFF AT THE MALE/FEMALE JUNCTION OF THE SET SCREW AND REMAINED IN THE LOCKING SCREW. THE CROSSLINK WAS REMOVED WITH THE BROKEN PORTION OF THE EXTENSION CONNECTOR SCREW REMAINING IN PLACE OF THE HEAD OF THE BONE SCREW. THE BROKEN PORTION WAS NOT REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613008 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0316358W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CROSSLINK, SET SCREW