BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACDF STAND ALONE CERVICAL

    MDR report key: 23242631 · Received October 8, 2025

    Report

    Report Number
    3005180920-2025-00953
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    December 12, 2024
    Report Date
    October 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVE
    PMA / PMN Number
    K192906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-09-2025. MECTA C (TI PEEK) 03.18.110 MECTA-C SA TIPEEK CAGE 16X14X6X7° (K192906) LOT 2458934: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-06-2024 EXPIRATION DATE: 2029-05-27. 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. TWODEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT. MECTA C (TI PEEK) 03.18.206 MECTA-C SA - PLATE FLUSH LOCK H6 (K192906) LOT 2330141: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-03-2024 EXPIRATION DATE: 2029-02-26. 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. TWO DEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT. MECTA C (TI PEEK) 03.18.623 MECTA-C SA DRILL SCREW LOCK Ø3.8X16 (2X) (K192906) LOT 2457716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-03-2024 EXPIRATION DATE: 2029-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MECTA C (TI PEEK) 03.18.623 MECTA-C SA DRILL SCREW LOCK Ø3.8X16 (2X) (K192906) LOT 2320130: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-05-2023 EXPIRATION DATE: 2028-04-17. 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. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS FROM SURGERY THE PATIENT PRESENTED SIGNS OF SUPERFICIAL WOUND INFECTION. ANTIBIOTIC TREATMENT WAS ADMINISTERED AND SOLVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565422 ACDF STAND ALONE CERVICAL MECTA-C SA TIPEEK CAGE 16X14X6X7° OVE MEDACTA INTERNATIONAL SA 03.18.110 2458934

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention