BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRON S ACP SYSTEM

    MDR report key: 10312000 · Received July 22, 2020

    Report

    Report Number
    9617297-2020-00005
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 22, 2020
    Manufacturer
    U&I CORPORATION
    Product Code
    KWQ
    UDI-DI
    08800037503824
    PMA / PMN Number
    K190053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN ADVERSE EVENT OCCURED IN THE UNITED STATES ON (B)(6) 2020. DURING THE SURGERY WITH THE ASPIRON S ACP SYSTEM (FCA2049), THE SCREW PULLED THROUGH THE PLATE. THE PLATE WAS IMMEDIATELY REMOVED FROM THE PATIENT AND REPLACED WITH A SAME SIZE PRODUCT TO COMPLETE THE OPERATION. THE PRODUCT OF THE ISSUE HAS BEEN RETURNED, AND THE DHR(DEVICE HISTORY RECORD) OF IT HAS CONFIRMED THAT THERE IS NO PROBLEM. WE ARE CURRENTLY INVESTIGATING THE SPECIFIC CAUSE OF THE ISSUE, AND SALES OF SUSPENSION HAS BEEN NOTIFIED TO US IMPORTER UNTIL A CAUSE OF THE ISSUE IS FIGURED OUT. AND CORRECTION IS COMPLETED. WE WILL INVESTIGATE THE CAUSE AND IF THERE IS ANY FURTHER FOLLOW-UP, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT OCCURED IN THE UNITED STATES ON (B)(6) 2020. DURING THE SURGERY WITH THE ASPERONS ACP SYSTEM (FCA2049), THE SCREW PULLED THROUGH THE PLATE. THE PLATE WAS IMMEDIATELY REMOVED FROM THE PATIENT AND REPLACED WITH A SAME SIZE PRODUCT TO COMPLETE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775815 ASPIRON S ACP SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS (KWQ), PRODUCT CODE: KWQ KWQ U&I CORPORATION FCA2049 19H12004 08800037503824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other