BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM

    MDR report key: 11117832 · Received January 5, 2021

    Report

    Report Number
    3000327445-2021-00001
    Event Type
    Injury
    Date Received
    January 5, 2021
    Report Date
    January 4, 2021
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HSB
    UDI-DI
    07540194002662
    PMA / PMN Number
    K192710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BONE CANCER CONTRIBUTED TO THE NON-UNION OF THE BONE. ALSO, IT IS IMPORTANT TO NOTE THAT NONUNION IS PREVALENT IN THE FOREARM DUE TO THE DIFFICULTY IN MAINTAINING FULL IMMOBILITY. ARM MOVEMENT DURING NORMAL DAILY ACTIVITY EXPOSES THE HUMERUS AND FOREARM TO LARGE BENDING FORCES AS THEY ACT AS LEVERS. THEREFORE, IT IS OFTEN DIFFICULT TO ACHIEVE BONE UNION, ESPECIALLY WHEN THE BONE DEFECT IS LARGE WITH CANCEROUS BONE, AS IN THIS CASE. THE NONUNION CAUSED FATIGUE FAILURE OF THE EXPOSED SLIM ROD DUE TO CYCLIC CANTILEVER FORCES AT THE FRACTURE SITE. THE FACT THAT THERE IS NO VISIBLE PLASTIC DEFORMATION ON THE IMPLANT CONFIRMS THE FATIGUE FAILURE. FURTHERMORE, REVIEW OF THE MANUFACTURING FILES SHOWED THAT ALL DIMENSIONAL INSPECTIONS AND MATERIAL MECHANICAL PROPERTIES WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A SLIM ROD INSERTED INTO THE RIGHT ULNA OF A 6-YEAR-OLD PATIENT BROKE AT THE NONUNION SITE. THE NAIL WAS IMPLANTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11819 THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM SLIM ROD Ø2.0MM X 140MM HSB PEGA MEDICAL INC. SLM-20-140 160405-007 07540194002662

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention