MAUDE Adverse Event Report: UNKNOWN DENTAL AMALGAM

Patient Problems Chest Pain (1776); Headache (1880); Failure of Implant (1924); Nausea (1970); Tinnitus (2103); Vomiting (2144); Chills (2191); Dizziness (2194); Deformity/ Disfigurement (2360); Irritability (2421); Cognitive Changes (2551); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 06/24/2022

Event Type  Injury  

Event Description

I would like to request the fda investigate the incident described herein which caused life-threatening symptoms described in the (b)(6) dph (department of public health) complaints (b)(4) which resulted in five surgical extractions, embarrassment; disfigurement; emotional distress; permanent injury; interference with her advancement as a professional and severe impacts to his personal life; economic loss; and potentially permanent neurological damage with additional negative health implications for the remainder of his life.A summary of the events is as follows: the plaintiff was under the care of dr.(b)(6), p.C.(formerly dr.(b)(6), p.C.) from 2011 to 2017 in (b)(6), (b)(6) in 2017 in (b)(6), and (b)(6) in 2019 in (b)(6).The plaintiff alleges he began exhibiting minor to mild symptoms in late 2014/2015 which escalated to moderate in 2015 to 2017 to severe by 2020 to 2023 with minor symptoms still present.From 2015 to 2022, (b)(6) underwent numerous medical appointments and examinations with various medical providers and specialties to determine the root cause of an unknown medical condition.On (b)(6) 2022, a ears, nose and throat ct scan was completed by an external imaging provider.The ct scan did not reveal any new maxillofacial injuries, however, it did reveal four unmistakable areas located in or around my upper back molars.The ct scan interpreted specific areas in the molar as a specific color or representation of a condition.These conditions differed from the adjacent surfaces, areas, etc.Within any tooth or molar within my mouth or jaw with or without a cavity and/or filling.Furthermore, it was determined that the conditions or areas were in the region causing severe life-threatening symptoms around my head, jaw, ears, face, or throat.A summary of the findings is as follows: molar #14 appeared to contain a condition that significantly differed from the adjacent surfaces and other teeth, i.E., inferior material, foreign object, hole, or other damage/inferior treatment, approximately 9.56mm long x 3mm wide, and appeared to protrude through the exterior vertical surface of the molar.Molar #15 appeared to contain a condition that significantly differed from the adjacent surfaces and other teeth, i.E., inferior material, foreign object, hole, or other damage/inferior treatment, approximately 4mm long x 1.5mm wide, and appeared to protrude through the exterior vertical surface of the molar.Molar #4 appeared to contain a condition that significantly differed from the adjacent surfaces and other teeth i.E., inferior material, foreign object, hole, or other damage/inferior treatment, approximately 6.14mm long x 2.25mm wide and appeared to protrude through the exterior vertical surface of the molar.Molar #2 appeared to contain a condition that significantly differed from the adjacent surfaces and other teeth i.E., inferior material, foreign object, hole, or other damage/inferior treatment, that appeared to look like the letter "f", approximately 7mm long x 1.49mm wide with another inferior material, foreign object, hole, or other damage/inferior treatment below the "f", approximately 7.5mm long x 2.5mm wide and appeared to protrude through the exterior vertical surface of the molar.The incident is under investigation by dph, however, the list below includes some of the severe symptoms believed to be caused by the inferior materials, device, or damage: nausea/vomiting (3-6 times a day), noticeable cognitive challenges, very extreme and severe headaches, tinnitus, dizziness, distractibility, irritation, rapid eye twitching in one eye, chest pain, chills and other symptoms associated with high fever, infection or poisoning symptoms, however, i did not have a fever.As described in detail in the dph compliant, the symptoms subsided after the surgical extractions.

• Brand Name: DENTAL AMALGAM
• Type of Device: DENTAL AMALGAM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18941471
• MDR Text Key: 338256743
• Report Number: MW5153010
• Device Sequence Number: 1
• Product Code: OIV
• 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: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White