MAUDE Adverse Event Report: TITANIUM PLATES; JOINT, TEMPOROMANDIBULAR, IMPLANT

Device Problem Break (1069)

Patient Problems Diarrhea (1811); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Neck Pain (2433)

Event Date 02/01/2012

Event Type  Injury  

Event Description

Plates were installed to correct tmj symptoms.Debilitating spasms and pain in face, neck, and back.Did relieve but would have been better to do bone graft if i knew then what i know and experience now.Vasculitis unk origin.I've had 2 tia's and titanium plates in lower jaw have broken and are causing an infection.I now have daily bouts of diarrhea.Numerous ct scans and mri showed damage sustained to both brain lobes and cortex.Diminished brain function.These plates were placed in (b)(6) 1999.

• Brand Name: TITANIUM PLATES
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• MDR Report Key: 7784564
• MDR Text Key: 117383514
• Report Number: MW5079159
• Device Sequence Number: 1
• Product Code: LZD
• 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: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• 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: 57 YR
• Patient Weight: 86