BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNK LUMBAR INTERBODY FUSION CAGE SYSTEM

    MDR report key: 6668963 · Received June 26, 2017

    Report

    Report Number
    3008285983-2017-00002
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    March 8, 2017
    Report Date
    April 7, 2017
    Manufacturer
    L&K BIOMED CO., LTD
    Product Code
    MAX
    UDI-DI
    08806189875871
    PMA / PMN Number
    K151140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ACCORDING TO (B)(4), THE BROKEN CAGE WHICH WAS REMOVED FROM THE PATIENT WAS NOT RETURNABLE SINCE THE HOSPITAL KEPT IT. THIS COMPLAINT IS STILL UNDER INVESTIGATION. L&K BIOMED WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT IS COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINT WAS RECEIVED FROM (B)(4) ON MAR 14TH, 2017. ACCORDING TO COMPLAINT REPORT, SURGEON PERFORMED LATERAL INTERBODY FUSION AT L2 TO L3, MODEL# 3810-5010 LOT# 15070105,0 DEGREE, 50X18X10MM) ON (B)(6) 2017, PATIENT WAS ABOUT (B)(6) FEMALE NOT FAT AND HAVING GENERAL SHAPE. SINCE THE DISC SPACE WAS TOO NARROW, SURGEON TRIED TO WIDEN USING 8MM DISTRACTOR BUT FAILED, THEN FINALLY WIDENED DISC SPACE USING COPP, CURETTE AND 10MM DISTRACTOR. HE SELECTED 50X10MM CAGE, 0 DEGREE AND FILLED BONE AND BMP, BINDED CAGE AND CAGE HOLDER AND TRIED INSERTION BUT FAILED. HE REQUESTED BIGGER MALLET TO THE CIRCULATOR. IT WAS RECOMMENDED TO USE LATERAL SLIDE BUT HE DENIED AND ATTEMPTED TO INSERT MORE TIME BY MORE MALLETING. WHEN THE CAGE WAS INSERTED ABOUT 20% IT WAS BROKEN, AND HE JUST REMOVED CAGE HOLDER FROM THE SITE. HE ATTEMPTED TO REMOVE BROKEN CAGE SEVERAL TIMES BY USING PITUITARY BUT IT WAS NOT EASY TO REMOVE, HE USED ANOTHER GENERAL INSTRUMENT OF SYNTHES, GLOBUS BUT IT DIDN'T WORK. HE SHARPENED THE CAGE TEETH USING MIDAS DRILL AND BARELY REMOVED IT. RIGHT AFTER REMOVAL THE BROKEN CAGE, HE FINISHED REVISION SURGERY USING SAME SIZE OF GLOBUS DLIF EXPANDABLE CAGE. CAGE WAS INSERTED EASILY THROUGH SLIDE EQUIPPED WITH CAGE HOLDER AND FINISHED EXPANDING SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447575 LNK LUMBAR INTERBODY FUSION CAGE SYSTEM INTERVERTEBRAL FUSION DEVICE MAX L&K BIOMED CO., LTD 3810-5010 15070105 08806189875871

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O