BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 8165133 · Received December 14, 2018

    Report

    Report Number
    3000327445-2018-00004
    Event Type
    Injury
    Date Received
    December 14, 2018
    Report Date
    December 14, 2018
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    HSB
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EVALUATED SINCE IT WAS NOT RETURNED BY THE CUSTOMER. NEVERTHELESS, THE CUSTOMER PROVIDED X-RAYS OF THE FAILURE AS WELL AS THE FOLLOWING INFORMATION: "THE PATIENT SUFFERED FROM OSTEOGENESIS IMPERFECTA. INITIAL IMPLANTATION - (B)(6) 2014 IN (B)(6) DUE BROKEN RIGHT FEMUR IN (B)(6) 2014. TWO FD NAILS WERE INSTALLED IN LEFT FEMUR AND TIBIA AND TWO SPOKES WERE ALSO DONE IN RIGHT FEMUR AND TIBIA. AFTER REHABILITATION THE PATIENTS WAS ABLE TO WALK ON A WALKER AT LEAST 60 M AND CRAWL ONLY. IMPLANT REMOVAL ON THE LEFT FEMUR WAS DONE ON (B)(6) 2018 IN (B)(6) CLINIC (B)(6) BECAUSE OF BOTH LEGS AND NAIL BEEN BROKEN (ONE OF THEM AN FD NAIL). BRACING WAS DONE ON (B)(6) 2018 IN (B)(6) CLINIC (JUST AFTER SEVERAL DAYS OF THE CASTING). AGE - (B)(6) YO NOW. TIME IN SITU BEFORE IT BROKE - 4 YEARS 8 MONTHS." ANALYSIS OF THE PROVIDED X-RAY SHOW THE ABSENCE OF ANY PLASTIC DEFORMATION OF THE NAIL AROUND THE BREAKAGE INDICATES THAT THE FAILURE WAS MOST LIKELY DUE TO FATIGUE STRESSES. THERE IS NO APPARENT BOWING OF THE FEMUR, THEREFORE THESE STRESSES WERE PROBABLY DUE TO INCOMPLETE HEALING (NON-UNION) OF THE BONE FRACTURE THAT GENERATED CONTINUOUS LOADING OF THE IMPLANT DURING A LONG PERIOD OF TIME. FURTHERMORE, IT WAS NOT POSSIBLE TO REVIEW THE MANUFACTURING RECORDS OF THE COMPONENTS SINCE IMPLANT SIZE AND LOT# WERE NOT AVAILABLE. NEVERTHELESS, CONSIDERING THE TIME THAT THE IMPLANT WAS IMPLANTED IN THE PATIENT, IT DOES NOT SEEM PROBABLE THAT THE FAILURE OCCURRED DUE TO A MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    A FD IMPLANT BROKE IN A FEMALE PATIENT OF (B)(6) YO AFTER 4 YEAR AND 8 MONTHS OF BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005781 FASSIER-DUVAL TELESCOPIC IM SYSTEM FD NAIL HSB PEGA MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention