BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 21733647 · Received March 31, 2025

    Report

    Report Number
    3006742481-2025-00002
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 20, 2025
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    HRS
    PMA / PMN Number
    K140372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE PROTEAN FRAGMENT PLATING SYSTEM INCLUDES THE FOLLOWING WARNINGS: "THE PATIENT SHOULD BE INFORMED ABOUT THE IMPORTANCE OF FOLLOWING THE POST OPERATIVE REHABILITATION PRESCRIBED TO FULLY UNDERSTAND THE LIMITATIONS IN ACTIVITIES OF DAILY LIVING. THE PATIENT MUST BE WARNED THAT FAILURE TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS MAY CAUSE THE IMPLANT OR TREATMENT TO FAIL." "POTENTIAL FRAGMENT PLATING SYSTEM CONSTRUCT FAILURES SUCH AS IMPLANT BREAKAGE, LOOSENING, FIXATION FAILURE, DELAYED UNION, OR NON-UNION MAY OCCUR AS A RESULT OF NON COMPLIANCE TO POST OPERATIVE REHABILITATION, EXCESSIVE WRIST ACTIVITIES OR CONSTRUCT OVERLOADING." THE PATIENT LIKELY STRESSED THE PLATE BY LIFTING HEAVY WEIGHTS PRIOR TO FULL HEALING OF THE FRACTURE.

    Description of Event or Problem · 0

    A PATIENT'S METACARPAL PROTEAN FRAGMENT PLATE BROKE WHILE WEIGHTLIFTING SIX WEEKS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042007 SKELETAL DYNAMICS INC. PROTEAN FRAGMENT PLATING SYSTEM HRS SKELETAL DYNAMICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Required Intervention