FDA Adverse Event Injury Summary report: N

MECTALIF ANTERIOR

MDR report key: 18779932 · Received February 23, 2024

Report

Report Number
MW5151934
Event Type
Injury
Date Received
February 23, 2024
Report Date
February 20, 2024
Manufacturer
MEDACTA INTERNATIONAL SA
Product Code
OVD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE MECTALIF ANTERIOR LAG SCREW SYSTEM HAS HAD NUMEROUS PRODUCT DEFECTS, MALFUNCTIONS, AND ISSUES THAT HAVE DIRECTLY CAUSED ADVERSE EFFECTS TO MY PATIENTS. THIS PRODUCT HAS ALREADY BEEN RECALLED BY MEDACTA ONCE, AND YET THE PRODUCT CONTINUES TO ENDANGER MY PATIENTS AND FAIL BASIC QUALITY TESTS. THE MEDACTA INTERNATIONAL SPINE ENGINEERING TEAM DOES NOT ADDRESS THESE PROBLEMS AND HAS ACTIVELY CONSPIRED WITH THE MEDACTA USA SPINE TEAM TO COVER UP THESE PROBLEMS REPEATEDLY. THE COLLECTIVE MEDACTA TEAMS HAVE REPEATEDLY PUSHED MYSELF AND OTHER SPINE SURGEONS (ORTHOPEDIC SPINE AND/OR NEUROSURGEONS) TO USE THIS PRODUCT WHILE ACTIVELY KNOWING THAT THIS PRODUCT IS DEFECTIVE. IT IS MY UNDERSTANDING THAT SEVERAL MEDACTA USA SPINE EMPLOYEES HAVE EITHER QUIT AND/OR BEEN TERMINATED BECAUSE THEY REPORTED THIS PROBLEM TO SENIOR LEADERSIP, WHO PROMPTLY PUSHED THESE INDIVIDUALS OUT AND CONTINUED TO SELL THIS PRODUCT. THIS PRODUCT AND SUBSEQUENT TEAMS HAVE REPEATEDLY ENDANGERED MY PATIENTS' LIVES AND MY SURGICAL PRACTICE. THE SPECIFIC INDIVIDUALS DIRECTLY INVOLVED IN THIS COVERUP AND ALLEGED CRIMINAL ENTERPRISE ARE (B)(6). PLEASE INVESTIGATE THIS, THERE IS SUFFICIENT TEXT MESSAGES AND WHATSAPP MESSAGES THAT HAVE DIRECT DOCUMENTATION OF THIS KNOWLEDGE, COVERUP, AND COMPLETE DISREGARD FOR ETHICS AND LEGAL VIOLATIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1565573 MECTALIF ANTERIOR INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD MEDACTA INTERNATIONAL SA 03.30.302, 03.30.300, 03.30.301

Patients

Seq Age Sex Outcome Treatment
1 NA Prefer Not To Disclose Life Threatening MECTALIF ANTERIOR LAG PLATE