MAUDE Adverse Event Report: ORMCO CORPORATION PALATE EXPANDER; BRACKET, METAL, ORTHODONTIC

Device Problem Use of Device Problem (1670)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Nausea (1970); Blurred Vision (2137); Hot Flashes/Flushes (2153); Dizziness (2194); Depression (2361); Irritability (2421); Shaking/Tremors (2515); Sleep Dysfunction (2517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

Event Type  Injury  

Event Description

See attached summary.Nickel toxicity from pallet spreader and braces made with nickel.Braces were on from (b)(6) 2019 - (b)(6) 2022 age 10-13 male child.Was misdiagnosed with celiac (allergy) to gluten.Symptoms progressed to being allergic to several proteins and sugars (see attached).My son also presented with serious metal poisoning symptoms (see attached).Started when braces were put on and dissipated when removed (see attached).All symptoms reversed once the braces were taken off.Please note in what world do we allow orthodontists put toxic metal in children¿s mouths!!! severe nausea and abdominal pain.Acid reflux.Light headedness/dizziness, headaches.Episodes of passing out.Impaired vision ¿ blurriness.Trouble sleeping, sleeping, sleeplessness, night sweats.The shakes.Hot flashes.Irritability, mild depression and being withdrawn.Food "allergies.Aching joints.Loss of concentration.Loss of energy.Vitamin d deficiency.Diarrhea.(b)(6) orthodontic treatment started in (b)(6) 2019 (medical records can confirm the exact date).(b)(6) experienced an onset of symptoms approximately 2-3 months after having the device installed.The symptoms initially included abdominal pain and nausea.I took (b)(6) to his pediatrician sometime in early (b)(7) 2020 (medical records can confirm the exact date).The patient was initially diagnosed as having celiac disease (allergy to wheat) via tests ordered by his pediatrician with consult from dr.(b)(6) at chop in (b)(6) 2020 and further confirmed by an endoscopy and bloodwork that was performed in late (b)(6) or early (b)(6) 2020.At that time the doctor said he had an allergy to gluten, fructose and lactose (1 protein and 2 sugars).(b)(6) and i also attended dietician training and consultations.I immediately shifted (b)(6) to a gluten, lactose and fructose free diet.Some of the symptoms subsided but then continued.I continued to monitor everything he ate trying to eliminate all trace amounts of gluten from his diet- making all of his food, buying special food and not eating out.The allergies and symptoms persisted and worsened in 2020 and progressed to additional severe allergy to proteins (wheat, egg, diary, tree nuts, canola) and sugars (fructose, lactose, dextrose) throughout 2020 and into 2021.The doctor continued to order blood tests and see (b)(6) on a regular basis.I continued to identify additional allergens but started to realize that something was poisoning my son.Conditions continued to worsen to symptoms that included headaches, dizziness, passing out, body aches, tremors, blurred vision, sleeplessness, irritability, etc.All symptoms were typical of heavy metal poisoning.Mri was requested, and the composition of his braces needed to be known by the mri technician.When i contacted the orthodontist, i was sent (on (b)(6) 2021) the sds (safety data sheets) for the devices in (b)(6) mouth and i immediately realized they contained a high nickel content.I called the orthodontist and requested immediate removal of the metal from (b)(6) mouth.The orthodontist suggested that he cannot possibly be allergic because he would have mouth sores.I explained that there are different types of allergic reactions and his symptoms were consistent with metal poisoning.Dr.(b)(6) stated that the braces only contained trace levels of nickel to prevent corrosion.I showed him the sds sheets and he said he didn't even realize they had that high of a level of nickel.(b)(6) braces were removed on (b)(6) 2021 after being on for 3 years and 1 month.One day after realizing the braces contained ni.(b)(6) symptoms began to subside within days of removing the braces and continued to subside until they were entirely gone in 4 months.This suggests direct causation and confirms the misdiagnosis of celiac disease.There is a mountain of literature that suggests that children are exposed to toxic levels of nickel from oral devices/materials containing nickel.A nih study confirmed that children are being misdiagnosed with celiac disease when exposed to nickel.Nickel is continued a child toxic heavy metal similar to mercury, lead and chromium and also classified as a carcinogen.Nickel alloys should not be used in children.The accurate diagnosis is systematic nickel allergy syndrome which presents itself with symptoms in 10 -15% of the population.Even though the other percent of the population does not present with symptoms, they are still being exposed.Reference number: mw5117508.

• Brand Name: PALATE EXPANDER
• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION
• MDR Report Key: 16929748
• MDR Text Key: 315322535
• Report Number: MW5117509
• Device Sequence Number: 1
• Product Code: EJF
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White