BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASFORA ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 7853298 · Received September 6, 2018

    Report

    Report Number
    2135141-2018-00003
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    August 10, 2018
    Report Date
    September 6, 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. THE C6 FRACTURE CAUSED BY THE PATIENTS FALL REQUIRED A NEW PLATE SIZE TO BE USED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS PATIENT COMPLIANCE.

    Description of Event or Problem · 1

    MEDICAL DESIGNS, LLC (MDLLC) WAS CONTACTED ON 08/17/2018 AND INFORMED OF A REVISION SURGERY THAT HAD TAKEN PLACE ON (B)(6) 2018. THE ORIGINAL SURGERY HAD TAKEN PLACE ON (B)(6) 2018. ON (B)(6) 2018, THE SURGEON IMPLANTED A 2 LEVEL 41 MM PLATE (11-1106-FD2-41) AND TWO (2) 4.0 MM X 16 MM VARIABLE ANGLE LOCKING SCREWS (11-1106-FD7-16) AND FOUR (4) 4.4 MM X 16 MM RESCUE SCREWS (11-1106-FD9-16). FOLLOWING THE INITIAL SURGERY, IT WAS REPORTED THAT THE PATIENT WAS NONCOMPLIANT AND NOT FOLLOWING POST-OP INSTRUCTIONS AND CAME BACK TO THE OFFICE WITH RECURRENT NECK PAIN FOLLOWING A FALL. ACCORDING TO X-RAYS THE PATIENT SUFFERED A C6 COMPRESSION FRACTURE DUE TO THE ACCIDENTAL FALL. THEREFORE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 TO ADDRESS THE NEW FRACTURE BY REPLACING THE EXISTING 41 MM PLATE WITH A LONGER 44 MM PLATE. THE OLD PLATE AND SCREWS WERE REMOVED WITHOUT ANY DIFFICULTY AND THE SURGEON IMPLANTED A 2 LEVEL, 44 MM PLATE (11-1106-FD2-44) USING FOUR (4) 4.4 MM X 16 MM RESCUE SCREWS (11-1109-FD9-16) AT C4 AND C6. PATIENT IS SAID TO BE DOING WELL FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690939 ASFORA ANTERIOR CERVICAL PLATE SYSTEM ASFORA ANTERIOR CERVICAL PLATE SYSTEM KWQ MEDICAL DESIGNS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention