Astra Tech Implant System® EV 26301Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 3.0 S - 8 mm OsseoSpeed® · Class 2 · Implant
All models of ASTRA TECH Implant System EV (177)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Astra Tech Implant EV dental implant has 110 adverse event reports, with no deaths and 110 injuries. Most reports describe the implant failing to bond with the jawbone or being lost, and some describe use outside the labeled instructions. 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
- 110
- Deaths reported
- 0
- Injuries reported
- 110
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 07392532214127), received between Jun 16, 2023 and Aug 13, 2026 — classified as 110 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (82 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate82
- Off-Label Use30
- Loss of Osseointegration27
- Malposition of Device1
Patient problems
- Failure of Implant110
- Unspecified Infection17
- Osteolysis7
- Inflammation5
- Pocket Erosion4
- Implant Pain1
- Sinus Perforation1
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50239267 ↗InjuryAug 13, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50239232 ↗InjuryAug 13, 2026Off-Label Use; Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; Contraindication: 3.0 in lateral tooth area.
Patient problems: Failure of Implant
MAUDE report 50238517 ↗InjuryAug 3, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 50113871 ↗InjuryJul 17, 2026Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD INFLAMMATION.
Patient problems: Failure of Implant; Swelling/ Edema
MAUDE report 25853896 ↗InjuryJul 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25731783 ↗InjuryJul 6, 2026Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. THE IMPLANT WAS PLACED IN A POSITION THAT WAS CONTRAINDICATED.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25719304 ↗InjuryJul 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25690071 ↗InjuryJun 27, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD UNSPECIFIED INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25645367 ↗InjuryJun 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25505301 ↗InjuryJun 3, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25383357 ↗InjuryApr 22, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24957811 ↗InjuryApr 22, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24957793 ↗InjuryApr 15, 2026Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED DENTAL IMPLANT LOSS DUE TO AN INFECTION.
Patient problems: Failure of Implant
MAUDE report 24884269 ↗InjuryMar 25, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24694977 ↗InjuryMar 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24671309 ↗InjuryMar 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24663592 ↗InjuryMar 2, 2026Loss of Osseointegration
CUSTOMER REPORTED - 1 X IMPLANT LOSS 3 X 8 / 1 X FRACTURE 3.6 X ?
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24490115 ↗InjuryFeb 26, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24460393 ↗InjuryFeb 6, 2026Off-Label Use; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24279454 ↗InjuryJan 30, 2026Failure to Osseointegrate
CUSTOMER REPORTED IMPLANT LOSS. ¿CATASTROPHIC BONE LOSS AROUND IMPLANT 2 MONTHS PLACEMENT. PLACED ON (B)(6) 2025 WITH COVER SCREW. SEEN PATIENT ON (B)(6) 2026 MONTH REVIEW, IF RADIOGRAPH HAD BEEN OK WOULD HAVE ARRANGED TO REPLACE COVER SCREW WITH HEALING ABUTMENT. PA ATTACHED. SHOWED SIGNIFICANT BONE LOSS. DISCUSSED WITH IMPLANT MENTOR, (B)(6) , BOTH FELT EXPLANATION WAS BEST, WITH INTENTION TO HAVE ANOTHER ATTEMPT AT PLACEMENT IN A COUPLE OF MONTHS.¿
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24226111 ↗InjuryJan 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23945442 ↗InjuryDec 30, 2025Off-Label Use; Loss of Osseointegration; Off-Label Use; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23921124 ↗InjuryNov 28, 2025Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23672074 ↗InjuryNov 18, 2025Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23590168 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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