BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF POSTERIOR

    MDR report key: 23243716 · Received October 8, 2025

    Report

    Report Number
    3005180920-2025-00946
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 SEPTEMBER 2025: MECTALIF POSTERIOR (TI PEEK) 03.27.045 MECTALIF POSTERIOR TIPEEK 11X25X10 L5° (K133192) LOT 2320089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2023. EXPIRATION DATE: 2028-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.52.323 ENH. CANN. PEDICLE SCREW 6X40MM + NUT (1X) STERILE (K141988) LOT 2330053: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2024. EXPIRATION DATE: 2029-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN DUE TO A CAGE THAT MOVED POSTERIORLY AND THE CAUSE IS UNKNOWN. DURING THE SURGERY, THE SURGEON ALSO FOUND THAT A PEDICLE SCREW HAD LOOSENED ON THE RIGHT SIDE OF THE L4 VERTEBRAL BODY. AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON REVISED THE SCREW AND PLACED A NEW CAGE ONE LEVEL HIGHER (L3) FOR FUSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2586855 MECTALIF POSTERIOR MECTALIF POSTERIOR TIPEEK 11X25X10 L5° MAX MEDACTA INTERNATIONAL SA 03.27.045 2320089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention