BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 25236486 · Received May 20, 2026

    Report

    Report Number
    3006742481-2026-00008
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 20, 2026
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    HRS
    UDI-DI
    00841506101514
    PMA / PMN Number
    K122310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE GEMINUS VOLAR DISTAL RADIUS PLATING SYSTEM STATES THE FOLLOWING: "THE GEMINUS® VOLAR DISTAL RADIUS PLATING SYSTEM SHOULD ONLY BE USED BY SURGEONS WHO HAVE EXPERIENCE WITH THIS SYSTEM." "PLEASE REFER TO THE GEMINUS® DISTAL RADIUS PLATING SYSTEM'S SURGICAL TECHNIQUE GUIDE (MKT-0000500) TO REVIEW THE SURGICAL APPROACH AS DESCRIBED BY (B)(6), USA." THE SURGICAL TECHNIQUE GUIDE INCLUDES SURGICAL STEPS SPECIFICALLY FOR INSTALLATION OF THE OPTIONAL HOOK PLATE EXTENSION, INCLUDING MULTIPLE NOTES AND IMAGES TO AID WITH THE PLACEMENT OF THE DEVICE. BASED ON EXPERT CLINICIAN REVIEW OF FLUOROSCOPIC IMAGES FROM THE CASE, IT APPEARS THAT THE HOOK PLATE EXTENSION WAS PLACED TOO DISTALLY. NO DEVICE DEFECT WAS EVIDENT FROM THE PROVIDED IMAGES.

    Description of Event or Problem · 0

    THE VOLAR MARGINAL FRAGMENT WAS NOT ADEQUATELY REDUCED DURING IMPLANTATION OF A GEMINUS HOOK PLATE EXTENSION, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37749 SKELETAL DYNAMICS INC. GEMINUS HOOK PLATE HRS SKELETAL DYNAMICS INC. 00841506101514

    Patients

    Seq Age Sex Outcome Treatment
    1