• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC TMJ CONCEPTS; JOINT, TEMPOROMANDIBULAR, IMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TMJ SOLUTIONS, INC TMJ CONCEPTS; JOINT, TEMPOROMANDIBULAR, IMPLANT Back to Search Results
Device Problems Break (1069); Device Slipped (1584); Mechanics Altered (2984)
Patient Problems Headache (1880); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074); Swelling (2091); Thrombus (2101); Tinnitus (2103); Vertigo (2134); Chronic Obstructive Pulmonary Disease (COPD) (2237); Osteolysis (2377); Numbness (2415); Test Result (2695)
Event Date 11/08/2011
Event Type  Injury  
Event Description
Info only on the christensen mom tjr's, all my christensen implant surgeries were done at (b)(6) hospital, (b)(6) by dr (b)(6).Original surgery date: (b)(6) 2008, bilateral custom from 3d scan christensen mom tjr's (i was told by my surgeon, that all of my christensen implants were titanium, didn't know til last year when (b)(6) told me otherwise and confirmed by (b)(6) and he said christensen has disguised them to look like titanium.On (b)(6) 2008, surgery to re-fit custom christensen mom tjr's with maxillary fixation.On (b)(6) 2009, osteomyelitis left christensen tjr, removal of infected tjr hardware with debridement and drain put in; iv antibiotics, plasmapheresis, and hyperbaric oxygen therapy; (b)(6) 2009, new stock tmj christensen mom tjr and arthroplasty and maxillary fixation; (b)(6) 2018, removal of bilateral christensen mom tjr's, advanced mandible 10mm, condylar removal intra-oral incision bilateral and inter maxillary fixation two weeks.Dt broken/failed, loose hardware and loose and missing screws and bilateral fossa's completely flipped.Metallosis found but limited due to my body encapsulated the bad hardware.(my body finally did a good thing to prevent further damage from these horrible tjr's).Note: ((b)(6) 2018 - (b)(6) 2018) re-hospitalized due to continuous bleeding from right intra-oral incision; two dvt's formed in right lower leg, peroneal vein and inferior great saphenous vein dt iv dilaudid).Removal surgery done by dr (b)(6) at (b)(6) hospital, (b)(6) planned revision surgery within a month, i hope.Bilateral concept's custom nickel-free uhmwpe and titanium tjr's, entire mandibular advancement with all muscles/soft tissues/vessels and nerves as one unit forward and upwards at least another 10-15 min, i think.I'll know how much later, maxillary laforte 1 osteotomy to meet proper occlusion will mandible's new position; possible correction of lower tip insufficiency if needed; placement of platinum weights to right upper eyelid due to bell's palsy.Side effects from removal of tjr's bleeding profusely for 12 days straight; numb and swollen tongue; entire lower lip/chin/right cheek numb, and palsy of right side of lower lip.Reason for removal of christensen mom tjr's was initially noticed left-sided bell's palsy and shift in bite in (b)(6) 2012 when a temple university oral surgeon refused to see me and i've been searching 6 yrs to find a surgeon to see why that happened and why i'm having so much pain and severe headaches, swelling of both tmj's, and skin color changes along my face where tjr's were.Heard clunking noises, too.Extreme vertigo where i couldn't stand up and would fall on concrete.Tinnitus is very severe.Developed obstructive sleep apnea diagnosed in 2016 due to mandibular retrognathia.(also have central sleep apnea due to immune onset demyelination from previous silastic and teflon tjm implants and hasten by necessary opiates for chronic pain control for tmjd, headaches, immune disease peripheral and central neuropathies, and demyelination, cidp, copd and bronchiectasis lung pains, spinal stenosis, severe systemic osteoarthritis in ankle, knee, hips and wrist, partial small bowel obstructions, to name a few reasons on opiates.) when i saw dr (b)(6) for first time he said my tjr's were completely mobile, loose hardware, loose and missing screws in both condylar and fossa prosthesis on both sides and that both fossas had completely flipped.Incidental note, all of my 9 bilateral surgeries with christensen tmj implants since 1994.All were removed due to implant loosening, bad bone growth, and osteomyelitis due to broken and failed implants, except the last set of tjr's were not infected, and was in the longest as well.Pt is totally disabled and the report above was written by the pt.
 
Event Description
Add'l info received from reporter for mw5077304 on (b)(6) 2018.The pt searched for a dr to remove her christensen joints that were broken for 6 yrs.She is disabled from the effects of jaw implants.She has many auto immune issues.These occurred after her implants like the rest of us.She found a dr after all those years living with broken implants.The dentist put in tmj concepts.She has medicaid as she is disabled and no one would take her.He moved her lower jaw forward 43 millimeters and her face is completely paralyzed on one side now.Both sides are infected with abscesses.The oral surgeon put in an eyelid weight and did eye surgery.During surgery, the surgeon had trouble putting the screws in as her bone was soft.It also was black.She developed a sever corneal scratch during surgery or possibly while in the hospital.She has a lot of bleeding from inside mouth when moved lower jaw forward that much ripped open the inside wall of my tissue, and dark red blood oozing out of mouth.A week after surgery she had swelling under the left neck incision and it's been getting bigger, red, hard feeling, bigger than a plumb and it's gradually getting bigger.She now has swelling on the right.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TMJ CONCEPTS
Type of Device
JOINT, TEMPOROMANDIBULAR, IMPLANT
Manufacturer (Section D)
TMJ SOLUTIONS, INC
MDR Report Key7525484
MDR Text Key108862291
Report NumberMW5077304
Device Sequence Number0
Product Code LZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age47 YR
Patient Weight54
-
-