MAUDE Adverse Event Report: UNKNOWN DENTAL IMPLANTS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074); Deformity/ Disfigurement (2360); Osteolysis (2377); Dry Mouth (4485); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

In 1999 i had a bone graft and two dental implants placed at the front of my mouth after having experienced significant trauma due to a car accident several years prior.The maxillofacial surgeon, dr.(b)(6) was aware that there was not sufficient bone to hold the implants as verbally stated, further stating the implants were the best viable option.The two false teeth were too thick as a result there was no way the gums could grow over.The acting dentist, dr.(b)(6) suggested i use the rubber end of a toothbrush to help the gums grow over which i did twice a day everyday with no results.He then suggested i smoke cigarettes and drink coffee to match the new implants to my teeth.Neither of these "specialists" informed me of proper care for the implants or better/healthier alternatives.This procedure cost my family close to $(b)(6) and will more than likely cost me a similar dollar amount as insurance companies do not cover these issues and for which i do not have immediate funds to cover such costs.I have always brushed my teeth twice a day, flossed, and used an antibacterial rinse and have had regular dental cleanings.In the summer of 2020 dr.(b)(6) became concerned about the bone loss where the bone graft was and the implants themselves, suggesting a deep cleaning which i complied.Dr.(b)(6) stated he was concerned that this would spread of which i believe has and shared with several dentists in (b)(6) once i relocated due to employment needs.Once i relocated from (b)(6) back to the northwest, i began to notice significant shifting of my teeth and darkening of the gums just above the implants.I returned to dr.(b)(6) office where he has since retired and was met with adversity and i met with in kind.I have received two rounds of antibiotics from my current dentist dr.(b)(6) and have been told several different things by several different dentists: 1.) the posts are not set in the correct spot, you need new posts.2.) you just need a deep cleaning and the gums will go back over 3.) we don't need to remove the implants you need a waterpik to clean the implants.4.) the implants are failing 5.) you will never have a great smile so you'll have to manage with what you have.The aforementioned list are statements from oregon dentists.I had a beautiful flipper that matched my teeth and that was not causing me health issues prior to these costly implants.My gums were a nice healthy pink and my teeth were straight, now my teeth are crooked, my gums are red and purple, the implants are now more visible than ever and has resulted in physical issues including the chills, dry mouth, swollen/receding gums, teeth shifting, pain when eating, aesthetically unappealing teeth.I recently returned to both dr.(b)(6) to receive records, dr.(b)(6) stated he no longer had the records.I believe dr.(b)(6) knew the implants were bad then as he began to remove one then quickly placed it back in my mouth and becoming agitated.These implants need to be removed before i go septic of which symptoms are already there.I had also contacted the (b)(6) board of dentistry, the representative stated if he were (b)(6) he'd get rid of the records, further stating because it had been over two years there was no grounds for legal recourse.When i read the law it reads two years after noticeable issues not from date of procedure.I have contacted attorneys to see if this is true, one attorney stated he knew dr.(b)(6) and was not out to save the world another attorney stated they would not take up the case because nerve damage hadn't set in yet.I don't want to die from dental implant malfunction.Reference report: mw5118417.

• Brand Name: DENTAL IMPLANTS
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17142788
• MDR Text Key: 317337610
• Report Number: MW5118418
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female