BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAX 5.5 CT SPINAL SYSTEM

    MDR report key: 15750459 · Received November 8, 2022

    Report

    Report Number
    9617297-2022-00002
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 4, 2022
    Manufacturer
    INNOSYS CO., LTD.
    Product Code
    NKB
    PMA / PMN Number
    K181824
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS ASSUMED THAT THE D4.5 SIZE SCREW WAS INSERTED INTO THE SACRUM, WHICH RECEIVED A LOT OF LOAD, AND WAS BROKEN. THE SPECIFIC LOT NUMBER AND PART NUMBER OF THE SUPICIOUS SCREW HAS NOT BEEN CONFIRMED, BUT THE SCREW DIAMETER WAS CONFIRMED AS 4.5MM. (D4.5) ACCORDING TO THE SURGICAL TECHNIQUE PROVIDED TO SURGEON, THERE IS A NOTE "DO NOT USE A SCREW THAT IS SMALLER DIAMETER THAN THE 7.0MM SCREW FOR THE SACRUM". WE'VE RE-INFORMED THE DISTRIBUTOR AND SURGEON TO PROPER WAY TO USE IT. (B)(6) 2022. ACCORDING TO THE SURGEON, THE PATIENT HAS NO SPINAL INSTABILITY, AND THERE IS NO DISC MIGRATION. THE PATIENT IS DOING FINE WITH NO PAIN AND IS HEALING WELL. WE WILL CONTINUE TO MONITOR THE PATIENT AFTERWARDS TO SEE ANY CONTRIBUTING CHANGES.

    Description of Event or Problem · 0

    A FEMALE PATIENT HAD SURGERY TO INSERT 4 ANAX 5.5 CT SCREWS INTO L5-S1 ON (B)(6) 2022. THE SURGEON FOUND OUT THAT THE SCREW IN S1 WAS BROKEN ON (B)(6) 2022 AFTER REVIEWING THE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213498 ANAX 5.5 CT SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB INNOSYS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other