BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5

    MDR report key: 10008595 · Received April 29, 2020

    Report

    Report Number
    3005180920-2020-00259
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    March 30, 2020
    Report Date
    June 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831485
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAY 06TH 2020 WE HAVE RECEIVED THE ITEMS INVOLVED IN THE COMPLAINT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE CAGE 03.27.006 LOT 141273 DOESN'T PRESENT EVIDENT CRACKS OR DAMAGE NEITHER ON THE BODY NOR ON THE PYRAMIDS. THE CAGE 03.27.006 LOT 1822231 PRESENTS SOME SCRATCHES AND COATING DELAMINATION ON THE POSTERIOR SIDE OF THE IMPLANT AND DIRT IN THE THREAD IS PRESENT BUT NO DAMAGES ON THE PYRAMIDS ARE VISIBLE. THE OVERALL DIMENSIONS OF THE IMPLANTS (LENGTH, HEIGHT AND WIDTH) ARE CONFORMED AND THE HEIGHT OF THE PYRAMIDS ON BOTH SIDES IS IN TOLERANCE, THEREFORE, CONFORMED. CONSIDERING THE INFORMATION PROVIDED AND WHAT IS STATED ABOVE THE ROOTE CAUSE OF THE MOBILIZATION COULD BE THE NON-CORRECT COMPRESSION OF THE IMPLANTS DUE TO THE SCREW LOOSENING. THE SCRATCHES AND THE DAMAGES VISIBLE ON THE POSTERIOR SIDE OF ONE CAGE ARE PROBABLY DUE TO THE REMOVAL OF THE IMPLANT DURING THE REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 APRIL 2020: LOT 1822231: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2019. EXPIRATION DATE: 2024-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED ON THE (B)(6) 2020 BY MEDACTA MEDICAL AFFAIRS DIRECTOR: SHORTLY (FEW WEEKS) AFTER POSTERIOR LUMBAR STABILIZATION WITH TWO PLIF CAGES THE SURGEON DISCOVERS THAT BOTH CAGES HAVE MOVED, ALONG WITH ONE PEDICLE SCREW, AND THEREFORE REPLACES THEM WITH AN OBLIQUE CAGE. THERE IS NO REASON TO SUSPECT THAT A DEFECTIVE DEVICE ORIGINATED THIS PROBLEM WHICH IS MORE LIKELY DUE TO TECHNICAL REASONS OR PERHAPS PATIENT BEHAVIOUR. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 09 APRIL 2020: MECTALIF POSTERIOR (TI PEEK) 03.27.006 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5° (K133192) LOT 141273A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-OCT-2019. EXPIRATION DATE: 2024-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM SINCE 2016. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PLIF SURGERY WAS PERFORMED AT L4-L5 ON (B)(6) 2020. THE SURGEON DISCOVERED AT X-RAYS THAT THE ONE CAGE WAS BACKED OUT AND ANOTHER WAS ROTATED BETWEEN THE VERTEBRAL BODY SPACE. REVISION SURGERY WAS PERFORMED ON MARCH 30 (26 DAYS AFTER PRIMARY SURGERY). THE SURGEON REMOVED BOTH CAGES AND INSERTED THE MECTALIF OBLIQUE CAGE H9 X L5°. THE SURGEON DISCOVERED THE LOOSENING OF THE PEDICLE SCREW AT L5, SO THE SURGEON REPLACED THE 7MM PEDICLE SCREW WITH THE 7.5MM PEDICLE SCREW. PEDICLE SCREWS WERE NOT MEDACTA'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474675 MECTALIF (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5 SPINE INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 03.27.006 1822231 07630030831485

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention