BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYBER MEDICAL

    MDR report key: 18860075 · Received March 7, 2024

    Report

    Report Number
    3012966183-2024-00004
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    July 17, 2023
    Report Date
    March 1, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    PMA / PMN Number
    K192975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPECIFIED PART AND LOTS USED IN THE INITIAL SUREGERY WERE DISCARED, THEREFORE AN INVESTIGATION INTO THE FAILURE OF THE DEVICE CANNOT BE CONDUCTED. THE ROOT CAUSE IS INDETERMINATE WITH PRESENT INFORMATION.

    Description of Event or Problem · 0

    SITE: DR. (B)(6). PATIENT ID: (B)(6). ADVERSE EVENT: AN ADVERSE EVENT OCCURRED 4.5 MONTHS POST-OP (WENT ON FOR 3 WEEKS; (B)(6) 2023 TO (B)(6) 2024) WHERE THE SCREW WAS DISPLACED. THIS EVENT WAS CONTINUOUS, MILD, NOT SERIOUS, NOT LIFE THREATENING, UNANTICIPATED, BUT COULD HAVE A POSSIBLE RELATIONSHIP TO THE TYBER MEDICAL TRAUMA SCREW SYSTEM. THERAPY WAS REQUIRED BUT THE PATIENT RECOVERED WITHOUT SEQUELAE. THE SCREW WAS REMOVED FROM THE RIGHT 5TH METATARSAL ON (B)(6) 2023 WITHOUT INCIDENT AND NO OTHER VISITS WERE NEEDED. IT WAS CONFIRMED WITH THE DOCTOR THAT THE SCREW PARTIALLY MIGRATED OUT OF THE BONE BUT THERE WAS NO TRAUMA AS PER PATIENT. PATIENT IS STILL FUSED. SUBJECT DETAILS: 16-YEAR-OLD FEMALE. PRESENT COMORBIDITIES: N/A. PAST MEDICAL HX: N/A. OSTEOTOMY OF THE DISTAL 5TH METATARSAL ON THE RIGHT SIDE AND ON THE LEFT SIDE USING A TITANIUM SNAP-OFF SCREW (2.0MM DIAMETER, 12MM LENGTH, FULL THREAD) FOR BOTH PROCEDURES (IDENTICAL ON BOTH THE LEFT AND RIGHT FOOT) THIS PATIENT WAS DEEMED FUSED, CLINICALLY HEALED, AND RETURNED TO NORMAL ACTIVITY ALL AT 5 WEEKS POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745918 TYBER MEDICAL TITANIUM SNAP-OFF SCREW (2.0MM DIAMETER, 12MM LENGTH, FULL THREAD) HWC TYBER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Other