MAUDE Adverse Event Report: METAL PLATE IN NECK; PLATE, FIXATION, BONE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 08/01/2014

Event Type  Injury  

Event Description

I had a plate and screws put in my neck after replacement of two discs.I have been extremely sick and hurt since then.No one has been able to offer any explanation.I am still trying to get this plate out of my neck.And results and data for people to look at but i do not have the ability to enter in this crazy form.Please feel free to contact me.(b)(6).Fda safety report id# (b)(4).

• Brand Name: METAL PLATE IN NECK
• Type of Device: PLATE, FIXATION, BONE
• MDR Report Key: 15925457
• MDR Text Key: 304984618
• Report Number: MW5113654
• Device Sequence Number: 1
• Product Code: HRS
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: "ADD MED"
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White