MAUDE Adverse Event Report: SPINAL KINETICS, INC. M 6 SPINAL KINETICS; PROSTHESIS, INTERVERTEBRAL DISC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Paraplegia (2448)

Event Date 05/18/2015

Event Type  Injury  

Event Description

I had one spinal kinetics m6, the cern dislocated.It was a surgery necessary to remove the m6.The defect implant caused severe health problems.I am suffering incomplete paraplegia.I have a lawsuit against spinal kinetics in (b)(6).The expert witness found three constructional faults the m6.To my knowledge there a further lawsuits against spinal kinetics at the regional courts (b)(6), i also know, that in (b)(6) dozens of pts have defective m6 implants (dislocation of the polymer cem), so that a remove surgery was or is necessary.

• Brand Name: M 6 SPINAL KINETICS
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): SPINAL KINETICS, INC.
• MDR Report Key: 8084818
• MDR Text Key: 128009131
• Report Number: MW5081437
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 50 YR