MAUDE Adverse Event Report: UNKNOWN UNKNOWN NEODISC; PROSTHESIS, INTERVERTEBRAL DISC

Device Problems Entrapment of Device (1212); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Event Description

The patient reported, they had done a test study of the neodisc for his cervical spine and that their test failed.The patient also reported, scar tissue grew all the way around the device, so it had to be removed.And they got the third level fused.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN NEODISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17523617
• MDR Text Key: 321073631
• Report Number: MW5130565
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1