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Signals from Device Events
July 2020

Signals is a quarterly medical device adverse events newsletter.

Dental Implants
NOTE: The following Adverse Event data was extracted from the FDA MAUDE database using Device Events, a cloud-based software service that extracts, consolidates and provides comprehensive reports and trends on the millions of medical device adverse event reports that have been submitted to the FDA. 
     PRODUCT CODE - DESCRIPTION                                                                       
     DZE                       - IMPLANTS, ENDOSSEOUS, ROOT-FORM

Notes: 1 - Acronyms: Medical Device Reports (MDR) and Alternative
           Summary Reports (ASR)
       2 - Prior to June 2019, dental implant manufacturers predominately 
           used ASRs to report adverse event activity to the FDA. ASRs prior
           to June 2019 were not entered into the FDA MAUDE database. In June
           of 2019, 2,185,222 dental implant ASRs were imported into the FDA
           MAUDE database making them available for viewing and reporting. 


Top 10 Manufacturers of Dental Implants Reporting Adverse Events

Dental Implants - Adverse Event Trend - Recalls and Injuries (MDRs Only)

Dental Implants - Adverse Event Trend - Malfunctions (MDRs Only)

Dental Implants - Adverse Event Trend -  Deaths (MDRs Only)

Dental Implants Market Size, Share & Trends Analysis Report By Type (Titanium, Zirconium), By Region (North America, Europe, Asia Pacific, Latin America, MEA), And Segment Forecasts, 2020 - 2027

The global dental implants market size was valued at USD 4.6 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 9.0% from 2020 to 2027. Increasing applications of dental implants in various therapeutic areas along with increasing demand for prosthetics are some of the key factors expected to boost the market growth. Prosthetics play a major role in propelling the demand for these implants through oral rehabilitation, which helps in restoring oral function and facial form of a patient. Acceptance level for dental implants is increasing among patients and dental surgeons due to limitations of removable prosthetics, such as discomfort, lack of natural appearance, and need for maintenance. Prosthetics mounted on dental implants do not encroach soft tissues and enhance aesthetics, which is further expected to drive the market growth.
* * *
Dental implant contamination: 3 reasons behind a late-stage failure
November 7, 2019 - PERIO-IMPLANT - ADVISORY
Dental implant contamination can be prevented if one recognizes the etiology, signs, and symptoms in their incipient stages. Dr. Scott Froum analyzes the major causes of contamination resulting in late-stage failure.  
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What to Know About Dental Implant Complications and Failure
September 4, 2018 - Healthline - Early and late dental implant failure 
A dental implant is a metal post that’s surgically attached to the jaw bone to support an artificial tooth. Once in place, a restorative dentist or oral surgeon mounts a replacement tooth to the implant.

Dental implants have a high success rate, but some people experience dental implant failure. It’s estimated that about 5 to 10 percent of dental implants fail, either shortly after a procedure or months or years later.

If you’re scheduled to have dental implant surgery, or if you currently have an implant, here’s what you need to know about implant failure and other potential complications.The FDA’s clearance is for The Tether™, which uses patented methods and techniques developed by medical staff of Shriners Hospitals for Children — Philadelphia. It is the first commercially available product used specifically for VBT, anterior vertebral body tethering, a surgical procedure for patients with scoliosis who meet very specific criteria. VBT is an alternative to spinal fusion procedures. 

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Study determines reasons for dental implant failure and removal techniques
September 3, 2019 - DENTAL TRIBUNE 
ZURICH, Switzerland: Dental implants have become a great treatment option to replace missing teeth, and various treatment concepts have reported high success rates. Nevertheless, like in every medical procedure, biological complications can occur which may lead to complete implant failure and, consequently, in the worst-case scenario, to the removal of the implant. A recent study by researchers from the University of Zurich has revisited the reasons for implant failure and compared different removal techniques.  
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Allergy related to dental implant and its clinical significance
August 19, 2013 - PMC - US National Library of Medicine - National Institute of Health
The oral cavity provides an ideal and unique environment for study of biological processes involving metallic dental aids. Dental materials within the mouth interact continually with physiological fluids. Oral tissues are exposed to a veritable bombardment of both chemical and physical stimuli as well as the metabolism of many species of bacteria; yet, for the most part, oral tissues remain healthy. The pH of saliva varies from 5.2 to 7.8. Teeth, restorations, or any prosthesis including dental implants in the oral cavity have to function in one of the most inhospitable environments in the human body. They are subject to larger temperature and pH variations than most other parts of the body. Corrosion, the graded degradation of materials by electrochemical attack, is of concern particularly when dental implants are placed in the hostile electrolytic environment provided by the human mouth. Allergic reactions may occur from the presence of ions produced from the corrosion of implants. The present article describes various manifestations of allergic reactions due to implant material in the oral cavity.

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Device Events LLC is a Pennsylvania-based company that provides a cloud-based software service that extracts, consolidates and provides clear and comprehensive metrics and reports on the millions of complex medical device adverse event reports (MDRs) and recalls that have been filed with the FDA.
 · Our service helps all organizations associated with healthcare by providing them with clear, comprehensive and cost effective access to the most up to date information on problem medical devices. ·  We are committed to making information on problem devices easily accessible to our customers so they can improve health outcomes and patient safety while reducing risk for their organizations.  For more information visit our website at
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