BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

    MDR report key: 16917741 · Received May 12, 2023

    Report

    Report Number
    3005180920-2023-00355
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVE
    UDI-DI
    07630040725729
    PMA / PMN Number
    K192906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-APR-2023 LOT 2127224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2022. EXPIRATION DATE: 2027-03-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: RIGHT AFTER A SINGLE-LEVEL CERVICAL STABILIZATION SURGERY INVOLVING A INTERBODY CAGE AND AN ANTERIOR PLATE MECHANICALLY CONNECTED TO THE CAGE, THE XRAY IMAGE SHOWS THAT THE PLATE DETACHED FROM THE BODY OF THE CAGE. HOWEVER, THE SCREWS APPEAR TO BE WELL EMBEDDED IN BONE AND PROBABLY THE CONSTRUCT IS STABLE, WHICH IS ALSO CONFIRMED BY THE CLINICAL REPORT. THEREFORE, NO ADVERSE CONSEQUENCE SHOULD BE EXPECTED. UNDERSTANDABLY, THE SURGEON DECIDED TO REFRAIN FROM REINTERVENTION. A POSSIBLE CAUSE COULD BE THE PLATE WAS NOT FULLY ENGAGED WITH THE CAGE AT THE TIME OF INSERTION, BUT OF COURSE WE CANNOT STATE THAT THIS IS THE CASE. OTHER DEVICE INVOLVED: ACDF 03.18.206 MECTA-C SA - PLATE FLUSH LOCK H6 (K192906) LOT 2120801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2021. EXPIRATION DATE: 2026-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 92 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING THE FOLLOW UP VISIT, THE X-RAYS REVEALED A DISCONNECTION BETWEEN THE CAGE AND THE PLATE. PATIENT IS STABLE AND NON SYMPTOMATIC, THE FUSION OF THE VERTEBRAE APPEARS TO BE CORRECT AND NO REVISION SURGERY HAS BEEN PLANNED. THE SURGEON REPORTED THAT WILL MAINTAIN MONITORED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475686 ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7° SPINE MECTA-C SA TIPEEK CAGE OVE MEDACTA INTERNATIONAL SA 03.18.118 2127224 07630040725729

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention