BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOS ALPHA PLATE, LEFT, 14 HOLE

    MDR report key: 11344954 · Received February 18, 2021

    Report

    Report Number
    2032480-2021-00001
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 17, 2021
    Manufacturer
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    Product Code
    KTW
    PMA / PMN Number
    K160409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021 AOS RECEIVED A REPORT THAT THERE WAS A BREAKAGE OF A PROXIMAL HUMERAL PLATE (3024-014) INSIDE THE PATIENT, 5 WEEKS POST-SURGERY. ADDITIONALLY, THE BREAKAGE OF A SCREW (8110-028 OR 8110-030) WAS REPORTED. THERE WAS NO INFORMATION AVAILABLE FOR THE MECHANISM OF FAILURE FOR THE PLATE. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2020. THE INITIAL SURGERY WAS TO CORRECT A ANTERIOR LATERAL PROXIMAL HUMERAL FRACTURE. IT WAS REPORTED BY THE SURGEON THAT THE PLATE AND SCREW MAY HAVE BEEN USED WHEN A NAIL WAS CONSIDERED MORE APPROPRIATE TO TREAT THE FRACTURE, BUT THERE ARE NO EVIDENCE TO SHOW THE INITIAL FRACTURE PATTERN OF THE SURGERY. MORE INFORMATION WAS REQUESTED TO SEE IF A REVISION SURGERY WAS SCHEDULED OR PLANNED. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 AOS RECEIVED A REPORT THAT THERE WAS A BREAKAGE OF A PROXIMAL HUMERAL PLATE (3024-014) INSIDE THE PATIENT, 5 WEEKS POST-SURGERY. ADDITIONALLY, THE BREAKAGE OF A SCREW (8110-028 OR 8110-030) WAS REPORTED. THERE WAS NO INFORMATION AVAILABLE FOR THE MECHANISM OF FAILURE FOR THE PLATE. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2020. THE INITIAL SURGERY WAS TO CORRECT A ANTERIOR LATERAL PROXIMAL HUMERAL FRACTURE. IT WAS REPORTED BY THE SURGEON THAT THE PLATE AND SCREW MAY HAVE BEEN USED WHEN A NAIL WAS CONSIDERED MORE APPROPRIATE TO TREAT THE FRACTURE, BUT THERE ARE NO EVIDENCE TO SHOW THE INITIAL FRACTURE PATTERN OF THE SURGERY. MORE INFORMATION WAS REQUESTED TO SEE IF A REVISION SURGERY WAS SCHEDULED OR PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241282 AOS ALPHA PLATE, LEFT, 14 HOLE PROXIMAL HUMERAL PLATE KTW ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3024-014 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention