BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL

    MDR report key: 13446892 · Received February 3, 2022

    Report

    Report Number
    0009617544-2022-00011
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    November 11, 2021
    Report Date
    May 11, 2022
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    04546540449580
    PMA / PMN Number
    K121342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL, DIMENSIONAL, MATERIAL, AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. COMPLAINT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THE REPORTED CATALOGUE NUMBER WERE IDENTIFIED. XIA 4.5 SURGICAL TECHNIQUE GUIDE: ADVERSE EFFECTS: WHILE THE EXPECTED LIFE OF SPINAL IMPLANT COMPONENTS IS DIFFICULT TO ESTIMATE, IT IS FINITE. THESE COMPONENTS ARE MADE OF FOREIGN MATERIALS WHICH ARE PLACED WITHIN THE BODY FOR THE POTENTIAL FUSION OF THE SPINE AND REDUCTION OF PAIN. HOWEVER, DUE TO THE MANY BIOLOGICAL, MECHANICAL AND PHYSICOCHEMICAL FACTORS WHICH AFFECT THESE DEVICES BUT CANNOT BE EVALUATED IN VIVO, THE COMPONENTS CANNOT BE EXPECTED TO INDEFINITELY WITHSTAND THE ACTIVITY LEVEL AND LOADS OF NORMAL HEALTHY BONE. BENDING, DISASSEMBLY OR FRACTURE OF ANY OR ALL IMPLANT COMPONENTS. FATIGUE FRACTURE OF SPINAL FIXATION DEVICES, INCLUDING SCREWS AND RODS, HAS OCCURRED. ADDITIONAL WARNINGS FOR PEDIATRIC PATIENTS: THE SAFETY AND EFFECTIVENESS OF THE XIA 3 SPINAL SYSTEM HAS NOT BEEN ESTABLISHED FOR USE AS PART OF A GROWING ROD CONSTRUCT. THIS DEVICE IS ONLY INTENDED TO BE USED WHEN DEFINITIVE FUSION IS BEING PERFORMED AT ALL INSTRUMENTED LEVELS. GROWTH ROD CONSTRUCTS TYPICALLY REQUIRE REPEATED PLANNED LENGTHENING PROCEDURES UNTIL A DETERMINATION IS MADE THAT THE PATIENT IS READY FOR A FINAL FUSION PROCEDURE. GROWTH ROD PATIENTS ARE MORE SUSCEPTIBLE TO POST-OPERATIVE INFECTIONS AND WOUND-HEALING ISSUES, AS WELL AS THE POTENTIAL FOR IMPLANT BREAKAGE REQUIRING UNPLANNED SURGICAL PROCEDURES. THE PHYSICIAN SHOULD DISCUSS THESE AND ALL OTHER POTENTIAL COMPLICATIONS WITH THE PATIENT AND THE PATIENT¿S GUARDIAN. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE THE DURATION OF IMPLANTATION; THE DEVICE WAS ACTIVE FOR OVER 2.5 YEARS IN A PEDIATRIC GROWTH ROD PATIENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    A PATIENT WAS REVISED AFTER TWO XIA 4.5 TITANIUM EXTENDED CONNECTORS FRACTURED. THIS REPORT CAPTURES THE SECOND OF TWO CONNECTORS.

    Description of Event or Problem · 0

    A PATIENT WAS REVISED AFTER TWO XIA 4.5 TITANIUM EXTENDED CONNECTORS FRACTURED. THIS REPORT CAPTURES THE SECOND OF TWO CONNECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776535 XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 48135103 163518 04546540449580

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention