BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10292395 · Received July 17, 2020

    Report

    Report Number
    3006742481-2020-00004
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    April 21, 2020
    Report Date
    May 18, 2020
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HRS
    UDI-DI
    00841506105802
    PMA / PMN Number
    K171590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. THE TRICEPS WAS NOT SUTURED TO THE PROXIMAL ULNA PLATE AS SUGGESTED BY THE SURGICAL TECHNIQUE GUIDE, THEREFORE, CONCLUDING THAT THE SURGICAL TECHNIQUE GUIDE WAS NOT FOLLOWED. POTENTIAL FAILURES OF THE SYSTEM MAY INCLUDE DELAYED UNION, NON-UNION, LOOSENING OF FIXATION, MIGRATION OR FAILURE OF THE DEVICE, STRESS FRACTURES OF THE BONES, OR INCOMPLETE HEALING AS A RESULT OF EXCESSIVE ACTIVITY, OVERLOADING OR NONCOMPLIANCE TO POST-OPERATIVE REHABILITATION.

    Description of Event or Problem · 1

    LOSS OF FIXATION ON THE OLECRANON FRACTURE. MEDICAL INTERVENTION NEEDED 1 WEEK POST-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754643 SKELETAL DYNAMICS PROXIMAL ULNA PLATE HRS SKELETAL DYNAMICS Proximal Ulna Plate, 108mm, Right 00841506105802

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other