BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSLP EXPANSIONHEAD

    MDR report key: 3030129 · Received March 28, 2013

    Report

    Report Number
    3030129
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE FLANGES OF THE RIGHT SIDED SCREWS WERE BROKEN BUT WAS ABLE TO BE REMOVED. ON THE LEFT SIDE MULTIPLE FLANGES OF THE SCREW WERE BROKEN. THE LOCKING SCREW WAS ABLE TO BE REMOVED BUT THE SHAFT OF THE LEFT SCREW WAS NOT ABLE TO BE REMOVED AS IT EMBEDDED INTO THE BONE. NO PATIENT HARM: PLAN OF CARE DID NOT CHANGE AS A RESULT OF THE EVENT. THE DEVICE HAD BEEN IN PLACE FOR APPROXIMATELY ONE YEAR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CERVICAL PSEUDOARTHROSIS AT C5-6 STATUS POST ANTERIOR CERVICAL DISKECTOMY AND FUSION FOR CERVICAL DISK HERNIATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127799 CSLP EXPANSIONHEAD APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES SPINE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR