BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR TI-PEEK CAGE

    MDR report key: 7163361 · Received January 4, 2018

    Report

    Report Number
    3005180920-2017-00815
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 7, 2017
    Report Date
    February 2, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030833816
    PMA / PMN Number
    K160605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 JANUARY 2018 ON IMPLANT AND INSTRUMENTS INVOLVED: IMPLANTS: MECTALIF ANTERIOR STAND-ALONE CAGE CODE 03.31.008 LOT. 142311: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 DECEMBER 2016. EXPIRATION DATE: 2021-11-23. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTALIF ANTERIOR PLATE FLUSH H.14 MM CODE 03.30.202 LOT. 148305 (K124034): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2015. EXPIRATION DATE: 2020-05-05. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. INSTRUMENT: MECTALIF ANTERIOR TRIAL FLUSH - 31X24 - H.14 CODE 03.30.10.1272 LOT. 1654845: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MARCH 2017. NO ANOMALIES FOUND RELATED TO THE ISSUE.

    Additional Manufacturer Narrative · 1

    ON 09 JANUARY 2018 R&D DEPARTMENT PERFORMED THE FOLLOWING INVESTIGATION ON THE RETURNED ITEMS: THE CAGE 03.31.008 LOT 142311, THE PLATE 03.30.202 LOT 148305 AND THE TRIAL (B)(4) RECEIVED FROM THE COMPLAINTS WAS MEASURED AND THEY ARE ACCORDING THE SPECIFICATION, SPECIFIED BY THE DESIGN SURGEONS. THE E ALIF DEVICE FLUSH H.14 OVER IMPOSED ON THE TRIAL HAVE THE SAME SHAPE CONSIDERING ALSO THE TEETH DIMENSION. THE ROUTE CAUSE OF THE DIFFERENT FEELING IS THE SECTION CAN GIVE TO THE SURGEON THE FEELING OF A DIFFERENT FRICTION. THE DIFFERENCE FOR EACH SIDE IS 0.4MM FOR A SMALL AREA.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A TRIAL USING THE ALIF TRIAL FLUSH - 31X24 - H.14 - L.10°, IT FITTED CORRECTLY; HE THEN IMPLANTED THE PLATE H.14 AND THE CAGE 24X31X14 L. 10° BUT THE IMPLANT WAS LOOSE IN THE INTERVERTEBRAL DISC SPACE. THEREFORE, HE PERFORMED A SECOND TRIAL USING A BIGGER SIZE, ALIF TRIAL FLUSH - 27X35X16 L. 15°, IMPLANTING THEN THE CAGE 27X35X16 L. 15° THAT FITTED CORRECTLY. IT WAS SUPPOSED THAT THE FIRST TRIAL FLUSH HAD A DIFFERENT HEIGHT COMPARED WITH THE IMPLANT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A TRIAL USING THE ALIF TRIAL FLUSH - 31X24 - H.14 - L.10°, IT FITTED CORRECTLY; HE THEN IMPLANTED THE PLATE H.14 AND THE CAGE 24X31X14 L. 10° BUT THE IMPLANT WAS LOOSE IN THE INTERVERTEBRAL DISC SPACE. THEREFORE, HE PERFORMED A SECOND TRIAL USING A BIGGER SIZE, ALIF TRIAL FLUSH - 27X35X16 L. 15°, IMPLANTING THEN THE CAGE 27X35X16 L. 15° THAT FITTED CORRECTLY. IT WAS SUPPOSED THAT THE FIRST TRIAL FLUSH HAD A DIFFERENT HEIGHT COMPARED WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10097 MECTALIF ANTERIOR TI-PEEK CAGE ANTERIOR CAGE OVD MEDACTA INTERNATIONAL SA 142311 07630030833816

    Patients

    Seq Age Sex Outcome Treatment
    1 Other