Reported Reactions

Adverse event reports that FDA received

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AstraTech Impl EV 5.4S 6mm OS medical device reports that FDA received

Name type
Device brand name, as written on reports
Generic name
Implant endosseous root-form
Device type
Implant, endosseous, root-form (product code DZE)
Manufacturer given most often on reports
Dentsply Implants Manufacturing

What a report is

A report is not proof that the device was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.

Source: openFDA, Device Adverse Event Overview. The site read the page on .

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From March 2021 to August 2026, FDA received 221 medical device reports that name the brand AstraTech Impl EV 5.4S 6mm OS. A brand name is as the reporter or the manufacturer wrote it, so one product can have more than one spelling.

FDA received 42 reports in the 12 months to August 2026 and 41 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

What an MDR is

A medical device report: one submission to FDA about one event. It has the brand name, the generic name, the manufacturer, the product code, the event type and coded problems. Manufacturers and user facilities must send reports.

Data version

openFDA MAUDE release of 28 Sep 2026. Reports received through 31 Aug 2026.

Since the last update

FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

  • In April to June 2026, FDA received 13 reports that name the brand AstraTech Impl EV 5.4S 6mm OS.
  • In January to March 2026, FDA received 11.
  • In April to June 2025, FDA received 8.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updatesFeed of updates (RSS)

Event types by year

The event type is the classification that the reporter gave. The four terms are FDA's.

FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Reports that name AstraTech Impl EV 5.4S 6mm OS, by event type and by the year in which FDA received them

The table continues to the right.

YearReportsDeathInjuryMalfunctionOtherNot given
202133033000
202227027000
202348048000
202444044000
202539039000
202630030000

An event type in a report is not proof that the device was the cause. FDA does not verify the event type.

Malfunction

A malfunction report says that the device did not do what it was made to do. It can be with or without harm to a person.

Reports by month

Reports that name AstraTech Impl EV 5.4S 6mm OS, by month, five years to August 2026
051020222023202420252026

FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type in all reports that name AstraTech Impl EV 5.4S 6mm OS
Event typeReportsShare
Death00%
Injury221100%
Malfunction00%
Other00%
Not given00%
Source of the reports that name AstraTech Impl EV 5.4S 6mm OS
Report sourceReportsShare
Manufacturer report221100%
Voluntary report00%
User facility report00%
Distributor report00%
Not given00%

Each share is of the 221 reports that name this brand, not of the devices in use.

Device problems coded

Device problem codes in the reports that name AstraTech Impl EV 5.4S 6mm OS
Device problem (FDA code)ReportsShare
Failure to osseointegrate12255.2%
Loss of osseointegration5826.2%
Osseointegration problem3817.2%
Insufficient device problem information10.5%
Malposition of device10.5%
Separation failure10.5%

These are the device problem codes of FDA, as written on the report. One report can have more than one code. The table leaves out general codes such as "no apparent adverse event".

Patient problems coded

Patient problem codes in the reports that name AstraTech Impl EV 5.4S 6mm OS
Patient problem (FDA code)ReportsShare
Failure of implant21999.1%
Osteolysis198.6%
Inflammationinflammation177.7%
Pocket erosion73.2%
Implant pain41.8%
Abscessa collection of pus10.5%
Burning sensationa burning feeling10.5%
Hypersensitivity/allergic reaction10.5%
Swelling/ edema10.5%

Patient problem codes are mainly in reports sent since 2019, and the field is often empty.

Pages near this one

These links are for navigation. No count selected them. The page of the device type lists each brand name with product code DZE.

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. AstraTech Impl EV 5.4S 6mm OS: medical device reports that FDA received. https://reportedreactions.com/device/astratech-impl-ev-5-4s-6mm-os/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 28 Sep 2026. The files have the reports that FDA received through 31 Aug 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.

A report is in the count when a device in it has this brand name, after the site removes differences of punctuation and capital letters. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that AstraTech Impl EV 5.4S 6mm OS was at fault?

No. FDA says:

The submission of an MDR itself does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event.

Source: FDA Center for Devices and Radiological Health, About Manufacturer and User Facility Device Experience (MAUDE) Database. Content current as of . The site read the page on .

Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

What event types do the reports record?

Injury (221). The event type is the classification that the reporter gave: death, injury, malfunction or other. FDA does not verify it.

Who sent these reports?

Manufacturer reports (100%). These are the sources of the reports that name this brand.

Some reports come directly from user facilities (like hospitals) or device importers (distributors), while others come directly from manufacturers.

Source: openFDA, Device Adverse Event Overview. The site read the page on .

How does a person report a problem with a medical device?

FDA runs MedWatch, a program that takes voluntary reports about medical devices. The guide on how to report has the links.

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