BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW TWO-STEP REDUCER ENHANCED

    MDR report key: 8064123 · Received November 13, 2018

    Report

    Report Number
    3005180920-2018-00886
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON NOVEMBER 13, 2018; LOT 1850157: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 2018; NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 1 SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. VISUAL INSPECTION PERFORMED OCTOBER THE 30TH, 2018. PICTURES RECEIVED WITH THE COMPLAINT HAVE BEEN ALSO CONSIDERED 2 OUT OF THE FOUR RETAINING PINS (INTERFACE TO THE IMPLANT - PEDICLE SCREW HEAD) ARE MISSING, DUE TO FAILURE OF THE WELDING. THE CAUSE OF PIN BREAKAGE CAN BE EXCESSIVE STRESS RELATED TO EXCESSIVE REDUCTION FORCE APPLIED AND/OR OTHER FORCES (E.G. LATERAL BENDING), OR EXISTING DAMAGE/DEFORMATION OF THE PIN FROM A PREVIOUS SURGERY. THE INSTRUMENT SET INCLUDES BACKUP INSTRUMENTS.

    Description of Event or Problem · 1

    PLIF SURGERY WAS PERFORMED AT L4-S1. WHEN THE SURGEON TRIED TO INSERT THE SET SCREW WITH THE TWO-STEP REDUCER ENHANCED AT THE LEFT SIDE OF L4, THE SURGEON WAS NOT ABLE TO INSERT. AFTER MANY ATTEMPTS, THE SURGEON DISENGAGED THE INSTRUMENT AND DISCOVERED THE 2 PINS WERE MISSING. ALL THE PIECES WERE RETRIEVED. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED FOR ABOUT 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902523 PEDICLE SCREW TWO-STEP REDUCER ENHANCED SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1850157

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other