BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF OBLIQUE

    MDR report key: 25328463 · Received May 29, 2026

    Report

    Report Number
    3005180920-2026-00497
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030830549
    PMA / PMN Number
    K133192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MAY 2026 LOT 2123195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEPT-2021. EXPIRATION DATE: 2026-AUG-08. 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. R&D INVESTIGATION A MECTALIF OBLIQUE CAGE REF 03.26.034, LOT NO 2123195, BROKE DURING THE INSERTION. FROM THE PICUTER RECEIVED, THE DEVICE APPEARS FRACTURED INTO FOUR PIECES, WITH THE FAILURE LOCATED IN THE CENTRAL REGION, WHERE THE CAGE BODY HAS REDUCED THICKNESS. BASED ON THE EVENT DESCRIPTION AND THE OBSERVED FAILURE MODE, THE ROOT CAUSE OF THE COMPLAINT MAY BE ASSOCIATED WITH EXCESSIVE HAMMERING DURING THE INSERTION PHASE, POTENTIALLY DUE TO UNEXPECTED RESISTANCE ENCOUNTERED DURING THE PROCEDURE. DUE TO LIMITED VISUALIZATION, THE DEVICE MAY HAVE BEEN INADVERTENTLY IMPACTED AGAINST THE PATIENT`S BONE RATHER THAN PROPERLY ADVANCED INTO THE DISC SPACE. ACCORDING TO THE ADDITIONAL INFORMATION PROVIDED A TRIAL WAS NOT USED TO SELECT THE IMPLANT SIZE. A VERIFICATION TEST WAS CONDUCTED BY THE R&D DEPARTMENT USING A DEVICE OF THE SAME REFERENCE. DURING THE TEST, THE DEVICE WAS CONNECTED TO THE INSERTER AND IMPACTED AGAINST A BENCH VISE TO SIMULATE EXTREME RESISTANCE CONDITIONS. UNDER THESE CONDITIONS, THE CAGE FRACTURED INTO MULTIPLE PIECES, EXHIBITING FRACTURE PATTERNS CONSISTENT WITH THOSE OBSERVED IN THE COMPLAINT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT THE COMPLAINT CONCERNS AN INTRAOPERATIVE FRACTURE OF A MECTALIF OBLIQUE TIPEEK CAGE DURING L5-S1 IMPLANTATION, WITH PART OF THE FRACTURED CAGE LEFT IN THE PATIENT BECAUSE REMOVAL WAS CONSIDERED DIFFICULT. THE ONLY DOCUMENTED IMMEDIATE CLINICAL CONSEQUENCE WAS AN APPROXIMATELY 10-MINUTE PROLONGATION OF SURGERY. NO IMMEDIATE PATIENT INJURY WAS REPORTED. HOWEVER, BECAUSE NO RADIOGRAPHIC IMAGES ARE AVAILABLE, THE RETAINED CAGE PORTION CANNOT BE LOCALIZED OR EVALUATED. AS A RESULT, IT IS NOT POSSIBLE TO EXCLUDE POTENTIAL SECONDARY CLINICAL CONSEQUENCES, INCLUDING LOCAL SYMPTOMS, MECHANICAL EFFECTS ON THE FUSION CONSTRUCT, OR THE NEED FOR FURTHER MONITORING OR INTERVENTION.

    Description of Event or Problem · 0

    SPINAL FIXATION WAS PERFORMED AT L5-S1. WHEN THE CAGE WAS INSERTED BY HAMMERING IT IN, IT BROKE WHEN ABOUT 60% OF IT WAS INSERTED. BECAUSE IT WAS DIFFICULT TO REMOVE THE CAGE THAT HAD BEEN INSERTED BETWEEN THE VERTEBRAL BODIES, IT REMAINED IN THE PATIENT`S BODY. THE QUALITY OF THE PATIENT`S BONE SEEMED TO BE STRONG. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES (TOTAL SURGERY TIME WAS ABOUT 3 HOURS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380181 MECTALIF OBLIQUE MECTALIF OBLIQUE TIPEEK 12X28X7 L0° MAX MEDACTA INTERNATIONAL SA 03.26.034 2123195 07630030830549

    Patients

    Seq Age Sex Outcome Treatment
    1