BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPLESS LI PEDICLE SCREW SYSTEM

    MDR report key: 1294333 · Received January 23, 2009

    Report

    Report Number
    3005031160-2009-00007
    Event Type
    Injury
    Date Received
    January 23, 2009
    Date of Event
    November 17, 2008
    Report Date
    December 12, 2008
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MNI
    PMA / PMN Number
    K072282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED ON PRODUCT CURRENTLY IN X-SPINE INVENTORY AND WERE FOUND TO BE ACCEPTABLE TO THE PRODUCT SPECIFICATIONS. QUALITY ASSURANCE REVIEWED THE RELEVANT TEST DATA FOR POTENTIAL FAILURES AND DETERMINED THAT THE PRODUCTS ARE WITHIN THE DESIGN SPECIFICATION. A DEFINITIVE CAUSE CANNOT BE DETERMINED AT THIS TIME. CARE MUST BE TAKEN TO ENSURE THAT ALL SCREW CUPS ARE TIGHTENED AND ASSEMBLED CORRECTLY. LOOSENING OF THE CONSTRUCT IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH EACH DEVICE. THE DOCTOR DESCRIBED THE PATIENT AS NON-COMPLIANT, STATING THAT THE PATIENT FAILS TO WEAR HIS BRACE.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPINAL SURGERY - FUSION L4 TO S1. ACCORDING TO THE REPORTER: DURING A FOLLOW-UP APPOINTMENT WITH SURGEON, IT WAS FOUND THAT THERE WAS A DISASSOCIATION OF THE L4 RIGHT SCREW WITH SUBSEQUENT INFERIOR MIGRATION, AS WELL AS DISASSOCIATION OF THE S1 LEFT SCREW WITH SUBSEQUENT SUPERIOR MIGRATION. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPLESS LI PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI X-SPINE SYSTEMS, INC. X010-0026 73437

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT NO. 76536| LOT NO. 76372| X010-0022| X010-0023