BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF OBLIQUE

    MDR report key: 24454889 · Received February 26, 2026

    Report

    Report Number
    3005180920-2026-00138
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    June 22, 2022
    Report Date
    February 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831034
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 FEBR 2026. LOT 2121367: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2021. EXPIRATION DATE: 2026-JUN-10. 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. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPT. A REVISION SURGERY WAS PERFORMED A FEW DAYS AFTER L4-L5 FUSION DUE TO VENTRAL MIGRATION OF THE INTERBODY CAGE. THE AVAILABLE X-RAY IMAGE CLEARLY CONFIRMS THE OCCURRENCE OF CAGE MIGRATION. THIS EVENT IS MOST LIKELY RELATED TO INSUFFICIENT PRIMARY STABILITY, CONSIDERING THE VERY EARLY OCCURRENCE. THIS COULD BE ASSOCIATED WITH SEVERAL FACTORS, SUCH AS SUBOPTIMAL POSITIONING OR SIZING OF THE CAGE, ENDPLATE PREPARATION, OR INADEQUATE POSTERIOR COMPRESSION. PATIENT-SPECIFIC FACTORS MAY HAVE ALSO PLAYED A ROLE. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DRAW DEFINITIVE CONCLUSIONS REGARDING THE EXACT CAUSE OF THE MIGRATION. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING-RELATED ISSUE. ALTHOUGH IT CANNOT BE CONFIRMED, THE EVENT IS MOST LIKELY RELATED TO INSUFFICIENT PRIMARY STABILITY, CONSIDERING THE VERY EARLY OCCURRENCE. THIS COULD BE ASSOCIATED WITH SEVERAL FACTORS, SUCH AS SUBOPTIMAL CAGE POSITIONING OR SIZING CHOISE, COMBINED WITH POTENTIAL INTRAOPERATIVE VARIABLES, INCLUDING ENDPLATE PREPARATION OR POSTERIOR COMPRESSION.

    Description of Event or Problem · 0

    PRIMARY SURGERY PERFORMED ON (B)(6) 2022. SINGLE-SEGMENT SPONDYLODESIS L4-5 WITH MYSPINE MC, MUST + MECTALIF OBLIQUE. FIRST REVISION SURGERYPERFORMED ON (B)(6) 2022 DUE TO VENTRAL CAGE MIGRATION. SECOND REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TOTHE BREAKAGE OF THREE SCREWS ((B)(4)). NOTE: THE COMPLAINT WAS NOT NOTIFIED AT THE TIME THE FIRST REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281490 MECTALIF OBLIQUE MECTALIF OBLIQUE TIPEEK 12X32X12 L10° MAX MEDACTA INTERNATIONAL SA 03.26.085 2121367 07630030831034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention