BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS PEDICLE SCREW PERCUTANOUS TOWER ENH. JPN

    MDR report key: 8403896 · Received March 8, 2019

    Report

    Report Number
    3005180920-2019-00130
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    February 7, 2019
    Report Date
    April 2, 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 · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE ROOT CAUSE OF THE EVENT, DIFFICULTY IN THE DISENGAGEMENT OF THE MIS RELEASE SYSTEM FROM THE PERCUTANEOUS TOWER, COULD BE CAUSED BY THE POTENTIAL IMPINGEMENT BETWEEN THE MIS RELEASE SYSTEM (03.52.10.0511+03.52.10.0514 + 03.52.10.0513) WITH THE PERCUTANEOUS TOWER IN SOME CONDITION. THE MIS RELEASE SYSTEM IT'S NOT AVAILABLE TO TEST THIS CONDITION. DURING THE INSPECTION, IT WAS FOUND OUT THAT THE TOWERS PRESENT ONE OR MORE AXIAL PINS MISSED, DEFORMED. IT'S NOT POSSIBLE TO CLEARLY DEFINE THE CAUSE OF THIS EVENT (DEFORMATION OF THE PINS), BUT A POTENTIAL ROOT CAUSE COULD BE THE BENDING MANEUVER ON THE TOWER DURING DISENGAGEMENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 MARCH 2019: LOT 1852969: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2018. NO ANOMALIES FOUND RELATED TO ANY OF THE THREE REPORTED PROBLEMS (FAILURE OF COUPLING, PIN DEFORMATION AND PIN DETACHMENT). TO DATE, NO OTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT FOR ANY OF THE CLAIMED ISSUES. THREE ADDITIONAL DEVICES WITH THE SAME REFERENCE ((B)(4)) AND LOT (1852969) ARE INVOLVED IN THE COMPLAINT. OTHER DEVICES INVOLVED IN THE COMPLAINT ARE: MIS PEDICLE SCREW (B)(4) MIS RELEASE SYSTEM-SHAFT SHORT/JPN LOT 1850178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MARCH-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENT HAS EVER BEEN REPORTED ON THIS LOT. MIS PEDICLE SCREW (B)(4) MIS RELEASE SYSTEM-HANDLE LOT 1755363: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MARCH-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT. MIS PEDICLE SCREW (B)(4) MIS RELEASE SYSTEM-CAP LOT 1850177: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT.

    Description of Event or Problem · 1

    AFTER THE INSERTION OF THE PEDICLE SCREW, THE SURGEON WAS NOT ABLE TO DISENGAGE THE RELEASE HANDLE FROM THE INNER SLEEVE. THE SURGEON WAS ABLE TO DISENGAGE BY HAMMERING THE SLEEVE WITH THE HAMMER. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. AFTER SURGERY IT WAS NOTICED THAT 2 OUT OF 6 TOWERS USED IN THE SURGERY LOST AN AXIAL PIN AND 1 OUT OF 6 TOWERS BENT AN AXIAL PIN. IT WAS UNKNOWN WHETHER PIN LOOSING/BENDING DIRECTLY RELATED TO THE COMPLAINT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195745 MIS PEDICLE SCREW PERCUTANOUS TOWER ENH. JPN SURGICAL INSTRUMENT FOR SPINE SURGERY LXH MEDACTA INTERNATIONAL SA 1852969

    Patients

    Seq Age Sex Outcome Treatment
    1 Other