MAUDE Adverse Event Report: UNKNOWN IMPLANT, FIXATION DEVICE, SPINAL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

The patient reported that they had hardware in their back that was not working.The patient also reported their pain had progressed and was considerably worse.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANT, FIXATION DEVICE, SPINAL
• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533079
• MDR Text Key: 321150041
• Report Number: MW5139985
• Device Sequence Number: 1
• Product Code: JDN
• 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: 09/30/2015

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