BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TOWER ENHANCED

    MDR report key: 6705105 · Received July 12, 2017

    Report

    Report Number
    3005180920-2017-00370
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 12, 2017
    Report Date
    November 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE (B)(4) PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE HINGES OF THE INSTRUMENTS GOT BLOCKED OR PRESENT EXCESSIVE FRICTION. POSSIBLY DUE TO LACK OF LUBRICATION AND/OR FOREIGN BODIES BETWEEN THE SLIDING SHAFTS OF THE INFERIOR PART OF THE INSTRUMENT, RESULTING IN EXCESSIVE FORCE ON THE HINGES THAT CONSEQUENTLY GOT DAMAGED AND/OR BLOCKED. THIS INSTRUMENT IS MAINLY USED FOR ROD REDUCTION INTO THE PEDICLE SCREW. THE SAME MANEUVER CAN BE ACHIEVED WITH ALTERNATIVE INSTRUMENT INCLUDED IN THE SET. BATCH REVIEW PERFORMED ON (B)(6) 2017: LOT 1651675: 46 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE THIRD SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT.

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION WAS REPORTED AS AVAILABLE FOR INVESTIGATION BY THE INITIAL REPORTER, HOWEVER THE PIECE WAS NEVER SENT BACK TO MEDACTA INTERNATIONAL SA. THE COMPLAINT HAS BEEN CLOSED WITHOUT VISUAL INSPECTION OF THE ITEM. IN CASE OF ITEM RETURN, A FOLLOW-UP REPORT WILL BE SENT TO FDA. ON 18 SEPTEMBER 2017 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 25 SEPTEMBER 2017 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    DURING SURGERY, 6 LOCKING TOWERS JAMMED. THE SURGEON USED EXTRA INSTRUMENTATION TO COMPLETE THE SURGERY. THERE WAS A DELAY OF APPROXIMATELY 20-25 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENTATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489370 LOCKING TOWER ENHANCED SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other