Astra Tech Implant System® EV 26360Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 5.4 S - 6 mm OsseoSpeed® · Class 2 · Implant
All models of ASTRA TECH Implant System EV (177)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Astra Tech dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Most of the 112 reports describe the implant failing to bond with the jawbone or being lost, and some describe infection or bone loss around the implant. The reports include 112 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 114
- Deaths reported
- 0
- Injuries reported
- 114
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 07392532214523), received between Jun 20, 2023 and Sep 14, 2026 — classified as 114 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (71 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate71
- Loss of Osseointegration40
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Malposition of Device1
- Separation Failure1
Patient problems
- Failure of Implant111
- Unspecified Infection14
- Osteolysis12
- Inflammation11
- Pocket Erosion5
- Implant Pain2
- No Clinical Signs, Symptoms or Conditions2
- Abscess1
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756858 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755998 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50221792 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; peri-implantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50046183 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD INFLAMMATION.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25765844 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25715191 ↗InjuryJun 19, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25562600 ↗InjuryJun 18, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25551138 ↗InjuryJun 5, 2026Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE. IMPLANT DRIVER FUSED TO IMPLANT, AND THEY COULD NOT REMOVE.
Patient problems: Failure of Implant
MAUDE report 25410137 ↗InjuryJun 3, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO MOBILITY.
Patient problems: Failure of Implant
MAUDE report 25383490 ↗InjuryMay 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25159610 ↗InjuryMay 12, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25151165 ↗InjuryMay 5, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS ASSOCIATED WITH PERI-IMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25086793 ↗InjuryApr 27, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24999755 ↗InjuryApr 8, 2026Failure to Osseointegrate
CUSTOMER REPORTED IMPLANT LOSS. ACCORDING TO RUSSIAN REGULATION, THESE PRODUCTS ARE CONSIDERED UNSAFE AND HAZARDOUS, THEREFORE DS LLC IS NOT ALLOWED TO SHIP THEM. THE PRODUCTS MUST BE TERMINATED BY A SPECIAL COMPANY, THAT HAS A LICENSE FOR THAT KIND OF ACTIVITY & TYPE OF HAZARDOUS GOODS.
Patient problems: Failure of Implant
MAUDE report 24823606 ↗InjuryApr 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24793423 ↗InjuryApr 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24793387 ↗InjuryApr 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24788807 ↗InjuryApr 2, 2026Failure to Osseointegrate
CUSTOMER REPORTED IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 24769924 ↗InjuryMar 30, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24713093 ↗InjuryMar 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24621942 ↗InjuryMar 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24617984 ↗InjuryMar 4, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24511743 ↗InjuryFeb 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24365098 ↗InjuryFeb 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24348614 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page