BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10340911 · Received July 29, 2020

    Report

    Report Number
    3006742481-2020-00007
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 29, 2020
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    KYI
    UDI-DI
    00841506100340
    PMA / PMN Number
    K180744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE: THE FOLLOWING POTENTIAL RISKS OR DISCOMFORTS HAVE BEEN ASSOCIATED WITH CARPOMETACARPAL ARTHROPLASTY: DISASSOCIATION, LOOSENING OR MIGRATION OF THE PROSTHESIS, INFECTION, EROSION AND DEVASCULARIZATION OF THE TRAPEZIUM, MATERIAL SENSITIVITY REACTION, TENDON AND NERVE INJURIES, UNDESIRABLE SHORTENING OR LENGTHENING OF THUMB, STIFFNESS OF THE CMC JOINT, DISLOCATION OR SUBLUXATION DUE TO IMPROPER POSITIONING, WEAR AND DEFORMATION OF THE ARTICULAR SURFACES, INTRAOPERATIVE AND POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN AND INFECTION. THE DEVICE COMPONENT WAS NOT RETURNED FOR EVALUATION AND ALL INVESTIGATIONS WERE BASED ON REPORTED INFORMATION. BASED ON THE INVESTIGATION RESULTS, NO DEFINITIVE RELATION COULD BE ESTABLISHED BETWEEN THE PRODUCT AND THE REPORTED ADVERSE CONSEQUENCE.

    Description of Event or Problem · 1

    IMPLANT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804984 SKELETAL DYNAMICS STABLYX, CMC IMPLANT KYI SKELETAL DYNAMICS STABLYX, CMC Implant, Sz. 4 AN1704006 00841506100340

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other