BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 21764087 · Received April 3, 2025

    Report

    Report Number
    0009617544-2025-00027
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    December 9, 2024
    Report Date
    May 11, 2025
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    04546540560193
    PMA / PMN Number
    K142381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION. ADDITIONAL DATA: H3 THE LOT NUMBER WAS CONFIRMED TO BE HJJ.

    Additional Manufacturer Narrative · 0

    WE RECEIVED FOUR POSSIBLE LOT NUMBERS FOR THE DEVICE AND WILL UPDATE THE RECORD IF WE RECEIVE MORE INFORMATION. THE LOT NUMBER COULD BE H78, HJJ, H9N, OR HBM.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE REPORTED THAT IMAGING TAKEN APPROXIMATELY SIX MONTHS POST-OPERATIVELY REVEALED THAT THREE XIA 3 TITANIUM BLOCKERS MIGRATED. THE PATIENT THEN UNDERWENT REVISION SURGERY APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY. THIS RECORD CAPTURES THE FIRST OF THREE XIA BLOCKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655758 XIA 3 TITANIUM BLOCKER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US HJJ 04546540560193

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention