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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ CONCEPTS TMJ CONCEPTS

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TMJ CONCEPTS TMJ CONCEPTS Back to Search Results
Device Problem Break (1069)
Patient Problems Bacterial Infection (1735); Dry Eye(s) (1814); Non specific EKG/ECG Changes (1817); Facial Nerve Paralysis (1846); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Staphylococcus Aureus (2058); Seizures (2063); Swelling (2091); Burning Sensation (2146); Dizziness (2194); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388); Device Embedded In Tissue or Plaque (3165)
Event Date 10/21/2014
Event Type  Injury  
Event Description
In 2005 i had tmj concepts implanted bilaterally.Shortly after this it looked like i had a stroke.I felt dizzy a lot - unsteady.In 2013 my pain became unmanageable and i had severe swelling and burning on my right side.In the summer of 2013 i had a cat scan done and my oral surgeon (os) said i had heterotopic bone on the left side.In late 2013, i had an intra-oral procedure done to remove the bone growth on my left side.My os stated that my implant devices were fine.Afterwards i continued to experience severe burning and itching sensations in the joint and was in a lot of pain.I was told the pain i was experiencing was all in my mind and that my joints were fine so there was no reason for the pain and indicated that i was a drug seeker.They took me off all medication and put me on acupuncture.It didn't work.In desperation i requested my doctor order cat scans.The results showed both fossas were completely broken.The right joint is severely broken in a couple of places and the left side hinges are broken off.Masseter muscle is elongated and atrophied.During this time i was diagnosed with epilepsy and had an eeg, seizure.Brain waves show changes and were located on the front right lobe.My neurologist indicated that he thought the seizures were due to the severe swelling in my jaw joints.In early 2014, i underwent a seven hour surgery to remove the broken tmj concept prosthesis.The right side was so badly broken that the surgeon was unable to remove all of the metal and plastic pieces in my jaw.The left side was broken but not as bad.I was quite ill after the surgery throwing up blood and bile while my jaws were wired shut.Off all the surgeries i've gone through this was the worst.My broken devices were sterilized by the hospital after the surgery.I tried to pick them up a few days after the surgery but i was told my os wouldn't release them to me.Since the removal of my implants the intense burning and itching is gone.About a week after my surgery to remove the broken implants, i developed an infection.I was put in the hospital and had drainage tubes.The next day i had to undergo a surgical procedure today to drain the infection.I was told it was staphylococcus and it's spreading.I was in a tremendous amount of pain.I then had to have another surgery to remove the silicon block spacer in my jaw as the infection was not improving.I was assigned an infectious disease doctor that said the infection is localized at the fossa.I was put on a picc line and had to undergo another surgery to put in a new silicon block and additional drainage tubes.I woke up from the surgery and found i could not talk because my tongue had been wired shut by accident.I was finally released from the hospital after 5 surgeries to get the infection under control.I have drainage tubes that i must keep in for another week.I still have a good amount of swelling.My teeth are moving due to the arch bars.I also have paralysis on my right-side (mouth, eye brow and lid).My eye droops and won't shut so i'm using eye drops to keep it moist.I have a home health nurse helping me.I saw my os for a checkup and he's dismissing me again - stating it was my fault the medication isn't working to fight off the infection.
 
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Brand Name
TMJ CONCEPTS
Type of Device
TMJ CONCEPTS
Manufacturer (Section D)
TMJ CONCEPTS
MDR Report Key4207227
MDR Text Key4978179
Report NumberMW5038834
Device Sequence Number1
Product Code LZD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/22/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/22/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
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