MAUDE Adverse Event Report: SPINAL KINETICS LLC. M6 L; PROSTHESIS, INTERVERTEBRAL DISC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/17/2013

Event Type  Injury  

Event Description

Due to long-lasting back pain, i received the m 6 disc prosthesis from the (b)(4) from a neurosurgeon in (b)(4).This was launched in (b)(6) in 2005 without valid certification from a notified body as a medical product of risk class iii according to the eu regulation.Many affected persons from different eu countries and third countries including (b)(6) were abused as clinical test persons for the clinical study without their express consent to participate in this study, neither the manufacturer nor the neurosurgeons involved informed the affected persons about the risks, concomitant diseases and contraindications.The m 6 will continue to be marketed in (b)(6) and now also in (b)(6) and other countries without valid certification.Fda safety report id # (b)(4).

• Brand Name: M6 L
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC.
• MDR Report Key: 11207470
• MDR Text Key: 228430212
• Report Number: MW5098918
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 83