BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 17408322 · Received July 27, 2023

    Report

    Report Number
    3006742481-2023-00014
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 25, 2023
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    HRS
    UDI-DI
    00841506105826
    PMA / PMN Number
    K171590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE DISTAL ELBOW SET (WHICH INCLUDES PROXIMAL ULNA PLATES) INCLUDE CONTRAINDICATIONS ADVISING AGAINST USE ON PATIENTS WITH "INSUFFICIENT QUANTITY OR QUALITY OF BONE". THE COMPLAINANT DESCRIBED THE PATIENT AS HAVING PREVIOUSLY UNDERGONE MULTIPLE OPERATIONS FOR THE SAME FRACTURE (INITIALLY USING A COMPETITOR'S PLATE) AND HAVING "EXTREMELY BRITTLE BONE", AS EVIDENCED BY THE EMERGENCE OF OTHER FRACTURES DURING FOLLOW-UPS. THESE STATEMENTS WERE FURTHER SUPPORTED BY FLUOROSCOPIC IMAGES SHOWCASING SIGNIFICANT BONE LOSS AND THE PRESENCE OF A COMPETITOR'S "HOME RUN" SCREW WHICH HAD BROKEN OFF AT THE HEAD AND BEEN LEFT IN THE BONE. THIS PATIENT MAY NOT HAVE BEEN SUITABLE FOR IMPLANTATION OF THIS DEVICE GIVEN THE DISTAL ELBOW SET'S CONTRAINDICATIONS FOR PATIENTS WITH INSUFFICIENT QUANTITY OR QUALITY OF BONE.

    Description of Event or Problem · 0

    AN IMPLANTED PROXIMAL ULNA PLATE BROKE IN THE WEEKS FOLLOWING SURGERY. THIS PATIENT HAS A HISTORY OF SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755672 SKELETAL DYNAMICS INC. PROXIMAL ULNA PLATE HRS SKELETAL DYNAMICS INC. DJ2002017 00841506105826

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention