BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAX 5.5 CT SPINAL SYSTEM

    MDR report key: 12825821 · Received November 17, 2021

    Report

    Report Number
    9617297-2021-00009
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 16, 2021
    Manufacturer
    INNOSYS CO., LTD.
    Product Code
    NKB
    UDI-DI
    08800015998291
    PMA / PMN Number
    K181824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    *INITIAL REPORT - MFR REPORT # : 9617297-2021-00009 1. INVESTIGATION 1-1. IT IS ASSUMED THAT THE REPETITIVE LOADS FROM DAILY LIFE ON THE SURFACE STEP OF THE SCREW HEAD, CAUSED BY THE SANDING PROCESS HAVE RESULTED IN THE OCCURRENCE OF MICRO-CRACKS AND BREAKAGE OF THE SCREW. - WE HAVE CONFIRMED A MEANINGFUL INCREASE IN THE MAXIMUM FATIGUE STRENGTH OF THE SCREW, AS WE HAVE REDUCED THE SANDING RANGE ON THE SCREW HEAD. 2. FOLLOW-UP 2-1. DESIGN CHANGE OF ALL SIZE (ANAX 5.5 CT SPINAL SYSTEM BONE SCREW(B TYPE)) 2-2. MARKET WITHDRAWAL OF ANAX 5.5 CT SPINAL SYSTEM BONE SCREW(B TYPE) OF D6.5 AND D7.5 SCREWS - SINCE THIS SCREW BREAKAGE DOES NOT OCCUR FREQUENTLY IN CT SCREW, WE BELIEVE THAT IF THE USER RECOGNIZES THE ABOVE SAFETY ISSUES AND KEEPS PAYING ATTENTION WHEN SELECTING THE APPROPRIATE SCREW SIZE BEFORE THE OPERATION, THERE WILL BE NO PROBLEM IN USING THE CURRENT SCREW. - TO ENSURE ADDITIONAL SAFETY, WE REPLACED THE D6.5 AND D7.5 SCREWS, WHICH ARE HEAVILY LOADED AND USED IN THE LOWER PART OF THE SPINE. 2-3.WE SENT A ANAX 5.5 CT SPINAL SYSTEM BONE SCREW SAFETY INFORMATION(T.B.) TO ALL CUSTOMERS. 3. PATIENT'S PROGNOSIS 3-1. THERE ARE NO SPECIAL FINDINGS IN THE PATIENT'S HEALTH THAT HAVE BEEN ADDITIONALLY CONFIRMED SO FAR.

    Additional Manufacturer Narrative · 0

    THE MALE PATIENT HAD A SURGERY TO INSERT FOUR ANAX 5.5 ST SCREWS INTO L5-S1 ON (B)(6) 2021. THE SURGEON FOUND OUT THAT TWO SCREWS (PART NO.: CT6645, LOT NO.: 19H05033) IN S1 WERE BROKEN ON (B)(6) 2021 AFTER REVIEWING THE X-RAYS. WE ARE INVESTIGATING THE CAUSE OF THIS ISSUE WITH THE RETURNED SCREWS. IF THE BREAKAGE OCCURRED DUE TO THE PRODUCT DESIGN, WE WILL IMPROVE THE SCREW. ADDITIONALLY WE HAVE A PLAN TO CONDUCT A REMOVAL IN THE MARKET IF WE NEED A DESIGN CHANGE. WE CANNOT FIND ANY QUALITY PROBLEM BY REVIEWING THE DEVICE HISTORY RECORD (MANUFACTURING & INSPECTION) OF THE RELEVANT PRODUCTS SO FAR. THE PATIENT WILL CONTINUE TO BE MONITORED AFTERWARDS TO SEE ANY CONTRIBUTING CHANGES. WE WILL FOLLOW-UP REPORT AFTER FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    THE MALE PATIENT HAD A SURGERY TO INSERT FOUR ANAX 5.5 CT SCREWS INTO L5-S1 ON (B)(6) 2021.THE SURGEON FOUND OUT THAT TWO SCREWS (PART NO.: CT6645) IN S1 WERE BROKEN ON (B)(6) 2021 AFTER REVIEWING THE LAST SET OF X-RAYS.

    Description of Event or Problem · 0

    THE MALE PATIENT HAD A SURGERY TO INSERT FOUR ANAX 5.5 ST SCREWS INTO L5-S1 ON (B)(6) 2021. THE SURGEON FOUND OUT THAT TWO SCREWS (PART NO.: CT6645) IN S1 WERE BROKEN ON (B)(6) 2021 AFTER REVIEWING THE LAST SET OF X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730747 ANAX 5.5 CT SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB INNOSYS CO., LTD. CT6645 19H05033 08800015998291

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other