BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASFORA ANTERIOR CERVICAL PLATESYSTEM

    MDR report key: 7853296 · Received September 6, 2018

    Report

    Report Number
    2135141-2018-00002
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MEDICAL DESIGNS, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K143688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES, AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE. X-RAYS SHOWED A SOLID FUSION WITH ONLY TWO (2) OF THE EIGHT (8) SCREWS LOOSENING AND BACKING OUT. THE MOST PROBABLE ROOT CAUSE IS SUSPECTED DEVICE LOOSENING DUE TO THE MOTOR VEHICLE ACCIDENT.

    Description of Event or Problem · 1

    MEDICAL DESIGNS, LLC (MDLLC) WAS CONTACTED BY A SURGICAL TECHNICIAN ON (B)(6) 2018. THE TECH INFORMED MDLLC OF A REVISION SURGERY THAT HAD TAKEN PLACE ON (B)(6) 2018. THE TECH STATED THAT THE PATIENT WAS A (B)(6) MALE WHO HAD UNDERGONE A C3-6 FUSION ON (B)(6) 2017. AT THAT TIME THE SURGEON IMPLANTED A 3 LEVEL, 57MM AACP PLATE (11-1106-FD3-57) AND EIGHT (8) 4.0MM X 16MM VARIABLE ANGLE LOCKING SCREWS (11-1106-FD7-16). PATIENT WAS DOING WELL UNTIL THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND PRESENTED WITH RECURRENT NECK PAIN. X-RAYS IDENTIFIED THAT TWO (2) OF THE ORIGINAL SCREWS HAD LOOSENED AND BACKED OUT OF THE PLATE. HOWEVER, XRAYS CONFIRMED A SOLID FUSION. THEREFORE, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE TWO SCREWS THAT HAD BACKED OUT OF THE PLATE WERE REMOVED. NO OTHER HARDWARE WAS REMOVED. THERE WERE NO COMPLICATIONS DURING THE REMOVAL PROCESS. PATIENT IS SAID TO BE DOING WELL FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690949 ASFORA ANTERIOR CERVICAL PLATESYSTEM AACP SYSTEM (PLATES AND SCREWS) KWQ MEDICAL DESIGNS, LLC 11-1106-FD7-16

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention