BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM

    MDR report key: 16511523 · Received March 9, 2023

    Report

    Report Number
    3005180920-2023-00193
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 9, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630345732293
    PMA / PMN Number
    K221545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08-MAR-2023 LOT 2220027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2022. EXPIRATION DATE: 2027-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER REPORTED EVENT ON THE SAME LOT. NOTE: RECALL IS ON GOING.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER REF. (B)(4) MECTALIF ANT - LAG PLATE FLUSH H12 MM LOT. 2220027. THE FIXING SCREW OF THE COVER PLATE IS BROKEN. ANALYZING THE BREAKAGE SURFACE WITH A MICROSCOPE AND COMPARING IT WITH THE FRACTURE SURFACE OF A TESTED SCREW OF THE SAME BATCH, THE FOLLOWING ROOT CAUSE CAN BE IDENTIFIED: WHEN SPECIFIC COMBINATIONS OF GEOMETRICAL CONDITIONS MEET, THE PROTRUSION OF THE FIXING SCREW INSIDE THE LAG FLUSH PLATE IS LONGER THAN THE DEPTH OF THE FEMALE THREAD, CAUSING THE SCREW TO STOP ADVANCING DURING TIGHTENING AND BE CONSEQUENTLY STRESSED UNDER TORSION INSTEAD OF TRACTION. MODIFICATION OF THE IMPLANTS WILL BE MADE UNDER MR 038-23, TO PREVENT THE OCCURRENCE OF THIS ISSUE.

    Description of Event or Problem · 0

    DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS TIGHTENING THE ANTI BACK OUT LAG COVER PLATE, THE SURGEON THOUGHT HE HAD LOCKED THE PLATE. THE SURGEON THEN REMOVED THE PLATE HOLDER ALONG WITH THE DRIVER AND THE SURGEON THEN NOTICED THAT THE ANTIBACKOUT COVER PLATE WAS STILL ATTACHED TO THE PLATE HOLDER. THE SURGEON ALSO OBSERVED THAT THE TOP OF THE SCREW HAD BROKEN OFF FROM THE THREADED PORTION. THE SURGEON LEFT THE THREADED PORTION OF THE SCREW IN THE PLATE AND CONTINUED WITH THE CASE. NO POSTERIOR FIXATION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574641 MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM SPINE ANTERIOR PLATE FLUSH OVD MEDACTA INTERNATIONAL SA 03.30.301 2220027 07630345732293

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other