BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10583765 · Received September 24, 2020

    Report

    Report Number
    3006742481-2020-00008
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 24, 2020
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K153208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE FOR THE SYSTEM STATES THE INDICATIONS FOR USE AS: "THE IJS-E SYSTEM IS INTENDED TO PROVIDE TEMPORARY STABILIZATION OF THE ELBOW JOINT AFTER TRAUMA OR CHRONIC ELBOW DISLOCATION. FOR SAFE EFFECTIVE USE OF THE IMPLANT, THE SURGEON MUST BE THOROUGHLY FAMILIAR WITH THE SURGICAL TECHNIQUE FOR THE DEVICE, IMPLANT, AND ASSOCIATED INSTRUMENTS. POTENTIAL IJS-E CONSTRUCT FAILURES SUCH AS STRESS FRACTURES OF THE BONES, LOOSENING OF THE CONSTRUCT, INSTABILITY, DELAYED SOFT TISSUE HEALING, SOFT TISSUE IRRITATION, OR INCOMPLETE HEALING MAY OCCUR AS A RESULT OF NON-COMPLIANCE TO POST-OPERATIVE REHABILITATION, EXCESSIVE ELBOW ACTIVITIES OR CONSTRUCT OVERLOADING." FURTHERMORE, THIS DEVICE CONTRAINDICATIONS STATE: "THE IJS-E SYSTEM SHOULD NOT BE USED IF THE FOLLOWING ARE PRESENT: ACTIVE OR LATENT INFECTION, SEPSIS, INSUFFICIENT QUANTITY OR QUALITY OF BONE (BONE LOSS GREATER THAN 30% OF THE TOTAL ARTICULATION OR INVOLVING AN ENTIRE COLUMN OF THE DISTAL HUMERUS, CORONOID BONE LOSS OF 50% OR MORE) AND/OR SOFT TISSUE, MATERIAL SENSITIVITY, OR PATIENTS WHO ARE UNWILLING OR INCAPABLE OF FOLLOWING POST OPERATIVE CARE INSTRUCTIONS. THE IJS-E SYSTEM SHOULD NOT BE USED IN PEDIATRIC PATIENTS OR PATIENTS WITH OPEN GROWTH PLATES." BONE LOSS GREATER THAN 30% OF THE TOTAL ARTICULATION WAS IDENTIFIED IN THE IMAGING PROVIDED VIOLATING THE CONTRAINDICATION LISTED ABOVE. THE PROCEDURE PERFORMED WAS AN INTERPOSITIONAL JOINT ARTHROPLASTY WITH PLACEMENT OF IJS WHICH IS NOT LISTED IN THE INDICATIONS FOR USE. PER FEEDBACK, THE PHYSICIAN DOES NOT BELIEVE THE DEVICE IS AT FAULT. NO DEVICE PROBLEMS WERE IDENTIFIED. REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PROBLEMS HAVE BEEN IDENTIFIED.

    Description of Event or Problem · 1

    IMPLANT REVISION 4 WEEKS POST UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047260 SKELETAL DYNAMICS INTERNAL JOINT STABALIZER OZI SKELETAL DYNAMICS IJS-E Base Plate Assembly 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR