BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTAB CANNULATED FENESTRATED POLYAXIAL SCREW Ø6.5 L40

    MDR report key: 22585667 · Received July 24, 2025

    Report

    Report Number
    3007728266-2025-00009
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    July 3, 2025
    Manufacturer
    SPINEART SA
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING FOLDER OF BATCH: 6-9855 HAS BEEN REVIEWED. THE PRODUCTION PROCESSES WERE CONFORM TO THE PREDEFINED SPECIFICATIONS AND THE QUALITY CONTROL PASSED. THERE WERE NO NON-CONFORMITIES OBSERVED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    AFTER WE RECEIVED THE COMPLAINT, THE MANUFACTURING DOCUMENTS AND QUALITY CONTROL DOCUMENTS WERE ANALYZED. RAW MATERIALS AND PRODUCTION PROCESSES WERE CONFORMING TO THE SPECIFICATIONS, AND NO NON-CONFORMITIES WERE IDENTIFIED. THE (B)(4) DEVICES FROM THIS BATCH WERE MANUFACTURED IN SEPTEMBER 2022, AND (B)(4) UNITS HAVE ALREADY BEEN IMPLANTED WITHOUT ANY ISSUES. ON 18 JULY 2025, WE ASKED FOR THE RETURN OF THE IMPLANT. THE REPORTER INFORMED US THAT THE IMPLANT WAS LOST DURING TRANSPORTATION. WE ASKED FOR XRAY IMAGES AND RECEIVED ONLY ONE PICTURE WHERE WE CAN SEE THAT THE SCREW IS BROKEN. UNFORTUNATELY, BASED ONLY ON THIS PICTURE, WE CANNOT DO ANY FURTHER INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE BREAKAGE.

    Description of Event or Problem · 0

    ON 16 JULY 2025, WE RECEIVED A COMPLAINT FROM THE FIELD (CPT-3991) FROM SPAIN. THE CUSTOMER COMPLAINT FORM STATES THAT A SCREW WAS BROKEN POST-OPERATIVELY AND THAT A REVISION SURGERY WAS DONE.

    Description of Event or Problem · 0

    ON 16 JULY 2025, WE RECEIVED A COMPLAINT FROM THE FIELD ((B)(4)) FROM SPAIN. THE CUSTOMER COMPLAINT FORM STATES THAT A SCREW WAS BROKEN POST-OPERATIVELY AND THAT A REVISION SURGERY WAS DONE. THE DEFECT WAS NOTICED DURING A FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187176 XTAB CANNULATED FENESTRATED POLYAXIAL SCREW Ø6.5 L40 XTAB CANNULATED FENESTRATED POLYAXIAL SCREW Ø6.5 L40 NKB SPINEART SA MPF-PX 65 40-S 6-9855

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention