BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER CERVICAL PLATING (SCP) SYSTEM

    MDR report key: 6143106 · Received December 2, 2016

    Report

    Report Number
    3005031160-2016-00091
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 3, 2016
    Report Date
    April 16, 2020
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP MDR TO 3005031160-2016-00091 SUBMITTED 12/02/2016. THIS FOLLOW-UP REPORT IS INTENDED TO REPLACE MDR 3005031160-2016-00102 SUBMITTED ON 12/21/2016 WHICH WAS INCORRECTLY SUBMITTED AS A FOLLOW-UP REPORT TO 3005031160-2016-00091.

    Description of Event or Problem · 0

    UPDATE DUE TO VISUAL EVALUATION OF THE REMOVED AND RETURNED PLATE; THE PLATE WAS NOT BROKEN AS DESCRIBED BY THE COMPAINANT, THE PLATE WAS DAMAGED AT THE PLACE WHERE THE SCREW MAKES CONTACT WITH THE PLATE. THE DAMAGE WAS SEEN ON THE INNER RIM OF THE FOUR CORNER SCREW HOLES.

    Additional Manufacturer Narrative · 1

    NO PARTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NOT RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE ORIGINAL DESCRIPTION; THE SURGEON PLACED THE SCREWS ONCE PAST THE POINT OF CLOSURE. HE WANTED TO TIGHTEN MORE AND IT HAS SWITCHED THE PLATE LEAVING THIS LOOSE. REVIEWING HE TAKE OUT THE PLATE AND REALIZED THAT THE PART WHERE THE SCREW RESTS WAS BROKEN. WAS REPLACED WITH THE SAME SCREWS USED. CLARIFICATION; I SPOKE TO REPRESENTATIVE ON THE PHONE AND VIA EMAIL AND SHE CLARIFIED; A SCREW WENT THROUGH THE PLATE, THE PLATE WAS BROKEN IN ONE PLACE AT THE EDGE, THE SCREW WAS NOT BROKEN. THE SAME SCREWS WERE USED AND A REPLACEMENT PLATE TO FINISH THE PROCEDURE WITH NO INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793695 SPIDER CERVICAL PLATING (SCP) SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY, CERVICAL KWQ X-SPINE SYSTEMS, INC. N60000107 165803

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R