BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7973283 · Received October 17, 2018

    Report

    Report Number
    3005180920-2018-00797
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831430
    PMA / PMN Number
    K133192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2018: LOT 1720591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 NOVEMBER 2017. EXPIRATION DATE: 2022-10-10 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. OTHERS DEVICES INVOLVED. MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X25X7 L0° REFERENCE (B)(4) (K133192) LOT 143917: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2015. EXPIRATION DATE: 2020-09-14 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. MECTALIF OFFSET INSERTER - INNER SHAFT REFERENCE (B)(4) LOT 1753707: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 OCTOBER 2017 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON (B)(4) 2018 FROM THE DESCRIPTION OF THE EVENT IT SEEMS THAT THERE IS A PROBLEM OF COUPLING IN THE THREADED AREA OF THE CAGES. A CHECK OF THE ROUTE CARD OF THE LOTS (143917 AND 1720591) SHOWN THAT THERE ARE NO OUT OF SPECIFICATION OR ACCEPTANCE IN DEROGATION. THE M4 THREAD OF THE PARTS IS CHECKED AT 100% IN THE FINAL CONTROL STEP. A DEEPER ANALYSIS CAN BE PERFORMED DURING THE VISUAL INSPECTION. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON (B)(4) 2018 FROM THE VISUAL INSPECTION OF THE TWO CAGES (REF(B)(4) LOT. 1720591 AND REF.(B)(4) LOT. 143917), IT'S POSSIBLE TO OBSERVE A DEFORMATION AT THE BEGINNING OF THE M4 THREAD. THIS DEFORMATION IS MORE VISIBLE ON THE CAGE 03.27.015. A TEST WITH AN M4 GO/NOGO GAUGE SHOWS A HIGH FRICTION OF THE GO GAUGE AND A VISIBLE MALPOSITIONING OF THE GAUGE. ALL THE CAGES ARE TESTED 100% DURING THE FINAL CONTROL SO THE DAMAGING OF THE THREAD OCCURRED DURING THE USAGE. TAKING INTO CONSIDERATION ALL THESE FACTS, THE ROOT CAUSE COULD BE IDENTIFIED INTO A CROSS-THREADING WITH THE RELATED INNER SHAFT. ALL THE PICTURES SUBMITTED IN THE COMPLAINT FOR WAS TAKEN INTO CONSIDERATION DURING THIS ANALYSIS.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT ABLE TO INSERT THE MECTALIF POSTERIOR CAGES INTO THE INNER SHAFT COMPLETELY. THE SURGERY WAS FINISHED WITH THE BACKUP IMPLANT. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED FOR ABOUT 10 MINUTES. THE INSERTING FRICTION FORCE OF BOTH CAGES IS HIGHER THAN THAT OF OTHER CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816892 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI POSTERIOR INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 1720591 07630030831430

    Patients

    Seq Age Sex Outcome Treatment
    1 Other