BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF TRANSFORAMINAL CAGES TIPEEK

    MDR report key: 21907228 · Received April 25, 2025

    Report

    Report Number
    3005180920-2025-00323
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030829284
    PMA / PMN Number
    K200551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 APR 2025. LOT 2463248: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2024. EXPIRATION DATE: 2029-11-28. 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. OTHER DEVICE INVOLVED: MECTALIF TRANSFORAMINAL (TI PEEK) 03.23.151 TRANSFORAMINAL INTERBODY FUSION DEVICE TIPEEK 12X30X8 L5° (K200551) LOT 2463925: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2024. EXPIRATION DATE: 2029-11-25. 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. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER TWO MECTALIF TRANSFORAMINAL TIPEEK CAGES, REF NO. 03.23.151, LOT NO. 2463248, ARE DAMAGED. IN ONE OF THE CAGES, ONE OF THE ENDPLATES, IN THE AREA OF CONNECTION WITH THE INSERTER, IS DEFORMED: THE ENDPLATE IS BENT, AND THE COATING IS CRACKED. IN THE OTHER CAGE, THE ENDPLATES ARE NOT DEFORMED, BUT THE COATING IS ALSO CRACKED. THE INSERTER USED DURING THE SURGERY WAS INSPECTED, AND IT FUNCTIONS PROPERLY. CONSIDERING THE DESCRIPTION OF THE EVENT AND THE DAMAGES TO THE CAGES, THE ROOT CAUSE OF THE COMPLAINT COULD BE THAT THE IMPLANT WAS TOO LARGE FOR THE PATIENT'S ANATOMY. AS A RESULT, IT WAS NOT POSSIBLE TO INSERT AND PIVOT THE DEVICE AS PRESCRIBED IN THE SURGICAL TECHNIQUE. AN EXCESSIVE FORCE WAS THEN APPLIED TO THE CAGE DURING HAMMERING, LEADING TO DEFORMATION OF THE IMPLANTS. THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    DURING SURGERY, THE SURGEON WANTED A 7MM TLIF CAGE, BUT THE CAGES START FROM 8MM SIZE. THE SURGEON TRIED TO INSERT THE CAGE 3 TIMES, ADJUSTING THE CAGE POSITION ON THE INSERTER EACH TIME (THE CAGE WAS AT 0° ON THE INSERTER). AFTER THREE FAILED INSERTION ATTEMPTS, THE CAGE GOT DAMAGED AND THE COATING CRACKED. A NEW CAGE FROM A DIFFERENT LOT ALSO GOT DAMAGED ON THE FIRST ATTEMPT. THE SURGEON DECIDED NOT TO INSERT A CAGE. 30 MIN OF DELAY IN THE SURGERY DUE TO THIS EVENT (TOTAL TIME 2.5 HOURS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484373 MECTALIF TRANSFORAMINAL CAGES TIPEEK MECTALIF TRANSFORAMINAL (TI PEEK) 03.23.151 TRANSFORAMINAL INTERBODY FUSION DEVI MAX MEDACTA INTERNATIONAL SA 03.23.151 2463248 07630030829284

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other