BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ILIZAROV SYSTEM

    MDR report key: 10049690 · Received May 12, 2020

    Report

    Report Number
    1020279-2020-01638
    Event Type
    Injury
    Date Received
    May 12, 2020
    Report Date
    September 9, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED FROM A LITERATURE REVIEW THAT THE PATIENT SUFFERED A POOR RANGE OF MOTION THAT WAS RESOLVED DURING FOLLOW UP. THE AFFECTED COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE A PRODUCT ANALYSIS COULD NOT BE PERFORMED. AS DEVICE INFORMATION WAS NOT MADE AVAILABLE, DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW CANNOT BE COMPLETED. THERE IS NO INFORMATION THAT WOULD SUGGEST THE DEVICE FAILED TO MEET SPECIFICATIONS. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO MEDICAL DOCUMENTS WERE RECEIVED FOR INVESTIGATION. THEREFORE NO MEDICAL ASSESSMENT CAN BE PERFORMED AT THIS TIME. THE REPORTED EVENT WAS PART OF THE HEALING PROCESS AND IT WAS RESOLVED DURING THE FOLLOW UP PROCESS. THE PAPER WAS PUBLISHED IN 2000.

    Description of Event or Problem · 1

    "THE ILIZAROV FIXATOR FOR PEDIATRIC AND ADOLESCENT SUPRACONDYLAR FRACTURE VARIANTS". AUTHOR: GUGENHEIM JOSEP J JR M.D. ACCORDING TO THE STUDY, ,MINIMALLY INVASIVE ILIZAROV TECHNIQUE OF FRACTURE TREATMENT UTILIZING SMALL DIAMETER PINS AND TENSIONED WIRES OFFERS A FAVORABLE ALTERNATIVE TO OPEN REDUCTION, AND INTERNAL FIXATION, AND IT CAUSES LITTLE DISRUPTION OF THE TISSUE BLOOD SUPPLY. ILIZAROV (SMITH AND NEPHEW, MEMPHIS, TN) FIXATORS WERE USED IN 13 CASES. IT WAS DOCUMENTED ON THE PAPER THAT 1 PATIENT ENDED UP WITH POOR RANGE OF MOTION THAT WAS RESOLVED DURING FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509580 UNKNOWN ILIZAROV SYSTEM PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R