BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10285924 · Received July 16, 2020

    Report

    Report Number
    3006742481-2020-00006
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 19, 2020
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    OZI
    UDI-DI
    00841506105
    PMA / PMN Number
    K153208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INSTRUCTIONS FOR USE WARNINGS STATE: 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. DURING REVISION, A LONGER AXIS PIN WAS USED. PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PROBLEMS HAVE BEEN IDENTIFIED FROM THE REVISION SURGERY. AS PER PHYSICIAN FEEDBACK THE PIN BACKING OUT WAS DUE TO THE MUSCULAR SIZE OF THE PATIENT.

    Description of Event or Problem · 1

    AXIS PIN BACKED OUT POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751412 SKELETAL DYNAMICS INTERNAL JOINT STABALIZER OZI SKELETAL DYNAMICS 00841506105

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other