BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 16397476 · Received February 17, 2023

    Report

    Report Number
    3000327445-2023-00001
    Event Type
    Injury
    Date Received
    February 17, 2023
    Report Date
    February 16, 2023
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    HSB
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SUFFERED FROM OSTEOGENESIS IMPERFECTA (OI). THIS DISEASE IS A GENETIC DISORDER CAUSING INCREASED BONE FRAGILITY AND LOW BONE MASS. PATIENTS WITH OI TYPICALLY ENDURE RECURRENT FRACTURES AND DEFORMITIES DUE TO BONE WEAKNESS AND THE SMALL SIZE OF THE BONE. THESE FRACTURES AND DEFORMITIES CAUSE CHRONIC PAIN AND LIMIT THEIR WALKING ABILITY AND THEY ARE OFTEN TREATED THROUGH SURGICAL PROCEDURES. INTRAMEDULLARY RODDING REMAINS THE BEST CHOICE FOR THE SURGICAL FIXATION OF THE BONE IN CASE OF FRACTURE OR DEFORMITY CORRECTION. CONSIDERING THE SMALL SIZES OF THE INTRAMEDULLARY CANAL, THERE IS A LIMIT OF THE SIZE OF THE INTRAMEDULLARY NAIL THAT CAN BE PLACED. THEREFORE, THE RISKS OF RE-FRACTURE OR BENDING ARE ALWAYS PRESENTED IN THIS PATHOLOGICAL BONE. NO MATTER WHAT NAIL OR ROD IS BEING USED, REVISION SURGERIES ARE A COMMON OCCURRENCE AS RODS HAVE BEEN SHOWN TO BEND OVER TIME, COUPLED WITH PROGRESSIVE LIMB DEFORMITY. THEREFORE, PATIENTS REQUIRE NEW RODS AS THEY GROW. THUS, THE RISK OF IMPLANT BENDING IS MOSTLY RELATED TO THIS UNDERLYING CONDITION AND IMPLANT FIXATION. MINIMIZING THIS RISK CAN BE ACHIEVED BY OPTIMIZING THE IMPLANT SIZES WITH THE MEDULLARY CANAL DIAMETER AND MAXIMIZING THE STABILITY OF THE BONE SEGMENTS. NEVERTHELESS, AN IMPLANT TOO LARGE CAN INDUCE BONE REABSORPTION AROUND IT (STRESS SHIELDING) BUT AN IMPLANT TOO SMALL CAN BEND OR BREAK MORE EASILY.

    Description of Event or Problem · 0

    FD IMPLANT WAS BENT INSIDE THE PATIENT REQUIRING EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116243 FASSIER-DUVAL TELESCOPIC IM SYSTEM FD NAIL HSB PEGA MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention