MAUDE Adverse Event Report: SPINE SOLUTIONS / SYNTHES PRO-DISC; ARTIFICIAL DISC REPLACEMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Reporter stated that he is receiving threats of arrest from the doctor and hospital if he continue to ask for copy of contracts.He has had experimental surgery ((b)(6)) and the doctor has not done anything that he said he would.His recurring symptoms include scar tissue in his back and abdomen, trouble walking and if he stays still too long, he locks up and is unable to move.He also has had an experimental mri.Reporter had lawyer sent request for copy of contracts that were signed, however, only received his surgery report.

• Brand Name: PRO-DISC
• Type of Device: ARTIFICIAL DISC REPLACEMENT
• Manufacturer (Section D): SPINE SOLUTIONS / SYNTHES
• MDR Report Key: 6940448
• MDR Text Key: 89249409
• Report Number: MW5072704
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 47 YR