BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRON ACP SYSTEM

    MDR report key: 7697404 · Received July 18, 2018

    Report

    Report Number
    9617297-2018-00006
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 17, 2018
    Manufacturer
    U&I CORPORATION
    Product Code
    KWQ
    UDI-DI
    08800015911542
    PMA / PMN Number
    K131200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SCREW AND PLATE WERE NOT REMOVED FROM PATIENT BODY AND PRODUCT INFORMATION WAS NOT PROVIDED. THEREFORE, WE CAN'T CHECK MANUFACTURING & INSPECTION RECORDS AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT WAS OPERATED WITH ANTERIOR CERVICAL PLATE SYSTEM ON (B)(6) 2018. AT THE TIME OF SURGERY THE SCREW WAS DOWN. 7 WEEK POSTOPERATIVELY, LOWER SCREW ON THE 2 LEVEL PLATE BACKED OUT A BIT. PATIENT IS FINE AND HAS NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539763 ASPIRON ACP SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ U&I CORPORATION 08800015911542

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other