BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L'DISQ

    MDR report key: 7734130 · Received July 31, 2018

    Report

    Report Number
    9617297-2018-00007
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    June 27, 2018
    Report Date
    July 31, 2018
    Manufacturer
    U&I CORPORATION
    Product Code
    GEI
    UDI-DI
    08800015900003
    PMA / PMN Number
    K132797
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS THE FIRST TIME AFTER L'DISQ WAS RELEASED IN 2012. ABOUT (B)(4) PRODUCTS(L'DISQ) HAVE BEEN SOLD UNTIL NOW. ALSO WE HAVE REVIEWED THE DEVICE HISTORY RECORD(MANUFACTURING & INSPECTION) OF L'DISQ(A18D101). BUT WE COULD NOT FIND ANY QUALITY PROBLEM IN DHR. WE THINK THAT THIS EVENT WAS CAUSED BY ENVIRONMENT OF PROCEDURE, ETC. VIA ABOVE INFORMATION. THEREFORE WE WILL KEEP MONITORING THE HEALTH STATUS OF PATIENT. REMAINED PART OF DEVICE WILL BE REMOVED FROM PATIENT'S BODY WHEN HE WANTS TO.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). THE PATIENT HAD DISC DISEASE BETWEEN L4 AND L5 VERTEBRAE. THE PATIENT UNDERWENT DISC DECOMPRESSION PROCEDURE ON (B)(6) 2018. PART OF DEVICE(L'DISQ) WAS BROKEN OFF IN PROCESS OF THE PROCEDURE AND REMAINS IN THE BODY. PATIENT DOES NOT HAVE ANY PAIN . AND PATIENT DOES NOT WANT TO UNDERGO THE REMOVAL SURGERY. THEREFORE PART OF DEVICE WILL BE REMOVED FROM PATIENT'S BODY WHEN HE WANTS TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575930 L'DISQ ELECTROSURGICAL DEVICE AND ACCESSRIES GEI U&I CORPORATION A18D101 08800015900003

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other