BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MIS ROD INSERT - ANGLED

    MDR report key: 8695293 · Received June 13, 2019

    Report

    Report Number
    3005180920-2019-00465
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971202665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 JUN 2019. LOT 1850291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE INSTRUMENT IS INTENDED TO INSERT IN CORRECT POSITION THE ROD. DUE TO SOME DIFFICULTS DURING THE REMOVAL OF THE INSTRUMENT FROM THE ROD, PROBABLY DUE TO CONTACT BETWEEN THE INSTRUMENT AND THE BONE, THE SURGEON HAMMERED THE ROD INSERTER CAUSING THE BREAKAGE OF THE WELDING AND THE CONSEQUENT ACCIDENTAL LOSS OF THE TIP OF THE INSTRUMENT. THE PART OF THE INSTRUMENT IS MADE OF BIO-COMPATIBLE MATERIAL (STAINLESS STEEL PER ASTM F899 AND ISO 16061) AND IS RADIOPAQUE THEREFORE IT WOULD BE SEEN IN THE X-RAY IMAGES ROUTINELY TAKEN DURING THE PROCEDURE. IN THE SET IS PRESENT A SECOND ROD INSERTER SO THAT THE SURGEON CAN CONCLUDE THE SURGERY WITHOUT WASTING TIME.

    Description of Event or Problem · 1

    DURING THE SPINE MIS SURGERY IT WAS DIFFICULT TO DISENGAGE THE ROD HOLDER FROM THE ROD (TIP BLOCKED ON THE ROD). THE SURGEON TRIED TO PULL IT OUT WITHOUT SUCCESS. HE USED ALSO AN HAMMER TO FORCE THE PART AND THE INSTRUMENT BROKE. IT WAS NOT POSSIBLE TO DISASSEMBLE THE INSTRUMENT TIP FROM THE ROD SO THE SURGEON HAD TO PERFORM AN ADDITIONAL CUT TO REMOVE THE INSTRUMENT PART. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT 1 HOUR OF DELAY EXPERIENCED IN THE SURGERY AND AN ADDITIONAL CUT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491608 PEDICLE SCREW MIS ROD INSERT - ANGLED SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1850291 07630971202665

    Patients

    Seq Age Sex Outcome Treatment
    1 Other