BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 11904570 · Received May 28, 2021

    Report

    Report Number
    3006742481-2021-00006
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 27, 2021
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    OZI
    UDI-DI
    00084150610490
    PMA / PMN Number
    K153208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR REVIEW/INVESTIGATION. THE IFU STATES: "THE DEVICE IS NOT DESIGNED TO WITHSTAND THE STRESS OF WEIGHT BEARING, LOAD BEARING, OR EXCESSIVE PHYSICAL ACTIVITY. DEVICE LOOSENING OR BREAKAGE MAY OCCUR WHEN THE IMPLANT IS SUBJECTED TO EXCESSIVE LOADING DURING SOFT TISSUE HEALING OR DELAYED HEALING". THE PATIENT SHOULD BE INFORMED ABOUT THE IMPORTANCE OF FOLLOWING THE POST-OPERATIVE REHABILITATION PRESCRIBED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT THE PATIENT WAS NON-COMPLAINT WITH THE POST-OPERATIVE INSTRUCTIONS AND PROCEDURES WHICH LIKELY CONTRIBUTED TO THE EVENT. FAILURE TO FOLLOW POST-OPERATIVE CARE CAN CAUSE THE TREATMENT TO FAIL.

    Description of Event or Problem · 1

    DECOUPLING OF AN IJS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801149 SKELETAL DYNAMICS INTERNAL JOINT STABALIZER OZI SKELETAL DYNAMICS 00084150610490

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention