BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNA LOCKING TROCHANTERIC NAIL

    MDR report key: 22910071 · Received August 27, 2025

    Report

    Report Number
    3003200961-2025-00001
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 28, 2025
    Manufacturer
    CG MEDTECH CO., LTD.
    Product Code
    HSB
    PMA / PMN Number
    K093707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE PROVIDED X-RAY IMAGES AND CLINICAL INFORMATION INDICATED THAT THE NECK SCREW FRACTURE WAS LIKELY DUE TO MULTIPLE CONTRIBUTING FACTORS: 1) PATIENT-RELATED FACTORS: X-RAY IMAGING SHOWED THAT THE FEMORAL NECK REGION DID NOT ACHIEVE UNION AFTER SURGERY AND CONTINUED TO DEMONSTRATE LATERAL DISPLACEMENT. A DELAYED UNION WITH REFRACTURE WAS CONFIRMED. AS A RESULT, EVEN WITHOUT EXTERNAL TRAUMA, PROLONGED LOADING COULD HAVE CAUSED FATIGUE FRACTURE OF THE SCREW. 2) WEDGE WING NON-DEPLOYMENT: THE WEDGE WING IS A DESIGN FEATURE INTENDED TO PROVIDE CUT-OUT RESISTANCE. HOWEVER, IF THE WING IS NOT DEPLOYED, THE LOAD DISTRIBUTION EFFECT IS REDUCED, CREATING A STRUCTURAL VULNERABILITY. THIS WAS THE FIRST REPORTED CASE OF A NECK SCREW FRACTURE. THE EVENT WAS CONSIDERED TO BE RELATED TO PATIENT CONDITION OR OTHER FACTORS THAN A MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL FOR A FOLLOW-UP EVALUATION OF SURGERY PERFORMED ON (B)(6) 2024, AT WHICH TIME A FRACTURE AT THE ANTERIOR PORTION OF THE NECK SCREW OF THE IMPLANTED DYNA LOCKING TROCHANTERIC NAIL WAS IDENTIFIED. THE CUSTOMER REPORTED THAT NO EXTERNAL TRAUMA (E.G., FALL) HAD OCCURRED THAT COULD HAVE CONTRIBUTED TO THE FRACTURE. ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE FRACTURED NECK SCREW WAS REMOVED AND REPLACED WITH A NEW ONE. THE PATIENT IS CURRENTLY REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520334 DYNA LOCKING TROCHANTERIC NAIL INTRAMEDULLARY FIXATION SYSTEM HSB CG MEDTECH CO., LTD. NGA2105 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention