BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR ALIF TRIAL FLUSH - 35X27 - H.12 - L.10°

    MDR report key: 7150724 · Received December 28, 2017

    Report

    Report Number
    3005180920-2017-00789
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 28, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 DECEMBER 2017. (B)(4). VISUAL INSPECTION PERFORMED ON THE RETURNED ITEMS BY R AND D PRODUCT MANAGER ON 20 DECEMBER 2017: THE RETURNED ITEMS WERE ANALYSED AND THEY ARE FOUND CONFORMING TO SPECIFICATION, NO ANOMALY FOUND. THE ROOT CAUSE OF THE DIFFERENT FEELING DURING ASSEMBLY IS PROBABLY DUE TO THE DIFFERENCE OF 0.4 (FOR EACH SIDE), BETWEEN THE TRIAL AND THE IMPLANT. ANYWAY THIS DIFFERENT IS ACCORDING THE SPECIFICATION OF THE DESIGN SURGEONS.

    Description of Event or Problem · 1

    THE DIMENSIONS OF THE TRIAL DID NOT MATCH WITH THE DIMENSIONS OF THE IMPLANT. THE TRIAL HELD TIGHTLY IN SITU, THE IMPLANT WAS LOOSE. A BIGGER IMPLANT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930132 MECTALIF ANTERIOR ALIF TRIAL FLUSH - 35X27 - H.12 - L.10° SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1651376

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other