BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM

    MDR report key: 16511522 · Received March 9, 2023

    Report

    Report Number
    3005180920-2023-00191
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 6, 2023
    Report Date
    April 6, 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

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER (ANALYSIS CONCLUDED ON 03-APRIL-2023). MECTALIF 03.30.10.2390 ALIF LAG TORQUE LIMITER STRAIGHT HANDLE 2.5NM - HL LOT: 2254942. THE TORQUE LIMITER HAS BEEN INSPECTED AND NO SIGN OF DAMAGE CAN BE FOUND. THE DEVICE HAS BEEN TESTED AND FOUND WITH THE CORRECT TOLERANCES OF 2.5 NM ± 10%. REF. 03.30.10.2300 ALIF T15 ANTI-BLACKOUT AND OFFSET SCREWDRIVER LOT: 2254973. BOTH SCREWDRIVERS HAVE BEEN INSPECTED AND NO SIGN OF DAMAGE CAN BE FOUND. THE PARTS ARE ACCORDING TO THE SPECIFICATIONS. REF. 03.30.301 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, SIGNS OF FRACTURE BY TORSION CAN BE SEEN. AFTER INTERNAL TESTS PERFORMED ON DEVICES 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.

    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. OTHER DEVICE INVOLVED: MECTALIF 03.30.10.2390 ALIF LAG TORQUE LIMITER STRAIGHT HANDLE 2.5NM - HL LOT 2254942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. RECALL IS ON GOING.

    Description of Event or Problem · 0

    DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS ADDING THE ALIF ANTI-BACKOUT LAG PLATE, THE TORQUE LIMITER HANDLE DID NOT GIVE OFF A "CLICK" SOUND TO INDICATE WHEN TO STOP TORSIONAL PRESSURE/FORCE. AS A RESULT, THE SURGEON KEPT TRYING TO SCREW IN THE FACEPLATE AND THE ANTIBACKOUT SCREW BROKE IN HALF. THE DISTAL TIP OF THE ANTIBACKOUT SCREW COLD-FUSED INTO THE FACEPLATE. THE SURGEON LEFT THE 4 PRIMARY SCREWS AS THEY WERE AND COMPLETED THE CASE WITHOUT THE ANTIBACKOUT PLATE. THE SURGEON PERFORMED A POSTERIOR FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574640 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 Female Other