BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI

    MDR report key: 12486766 · Received September 17, 2021

    Report

    Report Number
    3005180920-2021-00747
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    August 19, 2021
    Report Date
    September 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630040719780
    PMA / PMN Number
    K181970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 AUGUST 2021. LOT 1922678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2019. EXPIRATION DATE: 2024-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    4 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN WAS UNKNOWN. THE SURGEON TOOK X-RAYS AND IT WAS OBSERVED THE LOOSENING OF THE PEDICLE SCREW, NOT MEDACTA, AND THE BACK OUT OF THE CAGE. THE PATIENT'S BONE WAS OSTEOPOROTIC. THE SURGEON REVISED THE MECTALIF POSTERIOR TIPEEK 9X25X13 L10° AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390126 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI POSTERIOR INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 1922678 07630040719780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention