BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM X 55MM S-LOK POLYAXIAL SCREW

    MDR report key: 4784836 · Received May 18, 2015

    Report

    Report Number
    3005739886-2015-00048
    Event Type
    Injury
    Date Received
    May 18, 2015
    Date of Event
    March 14, 2015
    Report Date
    April 20, 2015
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PROBLEM ALREADY KNOWN, NO EVALUATION NECESSARY. A TREND FOR TULIP HEAD SPLAY IN THE DOMINICAN REPUBLIC WAS PREVIOUSLY IDENTIFIED AND A CAPA WAS INITIATED FOR FURTHER INVESTIGATION. INVESTIGATION IDENTIFIED THAT ALL COMPLAINTS RECEIVED REPORTING TULIP HEAD SPLAY AND INABILITY TO TORQUE THE LOCKING SCREW RECEIVED FROM THE DOMINICAN REPUBLIC ILLUSTRATE FAILURES OF THE SYSTEM CONSISTENT WITH CROSS-THREADING. TRAINING OF THE DISTRIBUTOR AND/OR SURGEON WILL BE PERFORMED BY A PRECISION SPINE, INC. REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED IN THE (B)(6) ON (B)(6) 2015, THE TULIP OF THE 6.5MM X 55MM S-LOK POLYAXIAL SCREW ((B)(4)) CROSS THREADED WHEN PROVIDING FINAL TORQUE TO THE S-LOK CAP SCREW. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER POLYAXIAL SCREW OF THE SAME PART NUMBER. A DELAY TO THE PROCEDURE OF 20 MINUTES RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321549 6.5MM X 55MM S-LOK POLYAXIAL SCREW MNI, MNH MNI PRECISION SPINE, INC. 2369TI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention