BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAX 5.5 SPINAL SYSTEM

    MDR report key: 11429796 · Received March 7, 2021

    Report

    Report Number
    9617297-2021-00006
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Report Date
    March 8, 2021
    Manufacturer
    U&I CORPORATION
    Product Code
    NKB
    PMA / PMN Number
    K132101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURED IN (B)(6). THE INFORMATION OF PRODUCT AND PATIENT IS UNKNOWN. THE DATE WHEN THE PROBLEM WAS OCCURED IS UNKNOWN. ALL THE INFORMATION RECEIVED IS AS BELOW.: THE PATIENT HAD A SURGERY FOR HIS/HER LUMBAR FUSION ON (B)(6) 2018, AND TWO SCREWS BROKE RECENTLY. AS SOON AS THE FURTHER INFORMATION IS RECEIVED, FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT HAD A LUMBAR FUSION ON THE (B)(6) 2018, WHERE TWO PEDICLE SCREWS BROKE RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323574 ANAX 5.5 SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB U&I CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1