MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 03.30.302, 03.30.300, 03.30.301

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

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 kris chavatte, phd (medacta international), meinrad feichter (medacta international), and daniel abromowitz (medacta usa).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.

• Brand Name: MECTALIF ANTERIOR
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA
• MDR Report Key: 18779932
• MDR Text Key: 336296694
• Report Number: MW5151934
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.30.302, 03.30.300, 03.30.301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MECTALIF ANTERIOR LAG PLATE
• Patient Outcome(s): Life Threatening
• Patient Sex: Prefer Not To Disclose