BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRON ACP SYSTEM

    MDR report key: 7697406 · Received July 18, 2018

    Report

    Report Number
    9617297-2018-00004
    Event Type
    Injury
    Date Received
    July 18, 2018
    Report Date
    July 17, 2018
    Manufacturer
    U&I CORPORATION
    Product Code
    KWQ
    UDI-DI
    08800015909877
    PMA / PMN Number
    K140234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACKED OUT SCREW WAS NOT REMOVED FROM PATIENT BODY. NO QUALITY PROBLEM WAS FOUND FROM MANUFACTURING & INSPECTION RECORDS OF LOT 16H216.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS OPERATED WITH ANTERIOR CERVICAL PLATE SYSTEM. A SCREW IN C4 HAS BACKED OUT POSTOPERATIVELY. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WAS NO REVISION SURGERY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539764 ASPIRON ACP SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ U&I CORPORATION 16H216 08800015909877

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other