BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS PEDICLE SCREW PERCUTANOUS TOWER ENH. JPN

    MDR report key: 8949449 · Received August 30, 2019

    Report

    Report Number
    3005180920-2019-00725
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 30, 2019
    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 26 JULY 2019: LOT 1854911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JAN-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE NO SIMILAR EVENT REPORTED. VISUAL INSPECTION PERFORMED BY MEDACTA SPINE R&D PROJECT MANAGER: PICTURE RECEIVED HAS BEEN TAKEN IN CONSIDERATION. THE SURGEON TRIES TO INSERT THE SETSCREW ON THE IMPLANT THROUGH THE PERCUTANEOUS TOWER WITHOUT SUCCESS DUE TO THE TOWER DIDN'T ENGAGE CORRECTLY THE IMPLANT. THIS EVENT COULD OCCUR DUE TO THE NOT CORRECT ENGAGEMENT BEFORE TO INSERT THE IMPLANT OR DUE TO A PARTICULAR MANEUVER PERFORMED BY THE SURGEON OR PARTICULAR SHAPES OF THE BONES. HOWEVER HAS BEEN OPENED AND CLOSED THE MR 036-19 THAT IMPROVE THE COUPLING WITH THE IMPLANT. THE INSTRUMENT INVOLVED IN THIS COMPLAINT WILL BE REWORKED TO THE NEW SPECIFICS. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 7 AUGUST 2019: MIS PEDICLE SCREW 03.52.10.0521 PERCUTANEOUS TOWER ENH. JPN LOT 1850084: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. 2X MIS PEDICLE SCREW 03.52.10.0521 PERCUTANEOUS TOWER ENH. JPN LOT 1850307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED (ONE IN THIS COMPLAINT). 2X MIS PEDICLE SCREW 03.52.10.0521 PERCUTANEOUS TOWER ENH. JPN LOT 1850636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 AUGUST 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, SEVEN SIMILAR EVENTS ON THE SAME LOT HAVE BEEN REGISTERED (2 PIECES INVOLVED IN THIS COMPLAINT).

    Description of Event or Problem · 1

    SPINAL FIXATION PERFORMED AT L5-S1 BY PPS. AFTER THE FINAL TIGHTENING OF THE S1, THE SURGEON USED THE REDUCER TO PERFORM THE REDUCTION AT L5. ALTHOUGH THE SURGEON WAS ABLE TO INSERT THE SET SCREW AT RIGHT SIDE OF L5 WITHOUT ANY PROBLEMS, THE SURGEON WAS NOT ABLE TO INSERT THE SET SCREW AT LEFT SIDE OF L5 EVEN WITH FULL ROTATION OF THE HANDLE. THE SURGEON ONCE LOOSENED THE FIXATION OF THE S1 AND DISENGAGED THE SET SCREW OF THE S1, AND TRIED TO INSERT THE SET SCREW OF L5 FIRSTLY, BUT THE SURGEON WAS NOT ABLE TO INSERT. THE SURGEON CONSIDERED THAT THE PERCUTANEOUS TOWER WAS NOT ABLE TO ENGAGE THE PEDICLE SCREW STRAIGHTLY, SO THE SURGEON CHANGED TO THE OPEN SURGERY. THE SURGEON WAS ABLE TO INSERT THE SET SCREW AT OPEN SURGERY WITHOUT ANY PROBLEMS. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. TOTAL SURGERY TIME WAS ABOUT 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743492 MIS PEDICLE SCREW PERCUTANOUS TOWER ENH. JPN INSTRUMENT FOR SPINE SURGERY LXH MEDACTA INTERNATIONAL SA 1854911

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other