BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTA C CERVICAL INTERBODY FUSION DEVICE TIPEEK "DOME SHAPED" 14X16X7 L5°

    MDR report key: 13558599 · Received February 18, 2022

    Report

    Report Number
    3005180920-2022-00136
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    ODP
    UDI-DI
    07630030833045
    PMA / PMN Number
    K142744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 FEBRUARY 2022. LOT 1923200: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JULY-2020. EXPIRATION DATE: 2025-JUNE-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. CAGE REVISION ON A (B)(6) OLD LADY 7 DAYS AFTER THE IMPLANTATION. ACCORDING TO THE REPORT, PATIENT REPORTED CERVICALGIA AND RADICULOPATHY C6. ON THE BASIS OF THE SINGLE LATERAL RADIOGRAFIC PROJECTION PROVIDED, IT CANNOT BE STATED THE POSITION OF THE CAGE NOR IF IT HAS MOVED AFTER THE SURGERY. THE REASON OF THIS EVENT CANNOT BE DETERMINED ON THE BASIS OF THE AVAILABLE INFORMATION. THERE IS NO REASON TO SUSPECT THAT A DEFECT OF THE DEVICE GENERATED THIS PROBLEM.

    Description of Event or Problem · 0

    HE CAGE WAS REVISED 1 WEEK AFTER THE PRIMARY FOLLOWING SUSPECTED CERVICALGIA AND PAINFUL-SENSORY C6 RADICULOPATHY LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537402 MECTA C CERVICAL INTERBODY FUSION DEVICE TIPEEK "DOME SHAPED" 14X16X7 L5° SPINE CERVICAL CAGE ODP MEDACTA INTERNATIONAL SA 03.28.722 1923200 07630030833045

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention