simply Legacy™3 Implant 854711URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of simply Legacy3 Implant (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Simply Legacy 3 dental implant is a root-form screw placed in the jawbone. Most of the 52 reports describe the implant failing to fuse with the surrounding bone, so it loosens or has to be removed, along with swelling, infection and tissue reactions at the site. There are 51 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
- 51
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10841307107866), received between Dec 5, 2018 and Jan 5, 2026 — classified as 50 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (32 reports).
2 other recalls cover devices cleared under the same FDA submission (K192221); they may or may not involve this specific model.
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 Osseointegrate32
- Positioning Failure6
- Osseointegration Problem5
- Positioning Problem4
- Material Deformation2
- Loss of Osseointegration1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant45
- Inflammation12
- Unspecified Infection10
- No Clinical Signs, Symptoms or Conditions6
- Osteopenia/ Osteoporosis6
- Granuloma5
- Inadequate Osseointegration4
- Pain4
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23968236 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474311 ↗InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23369599 ↗InjuryOct 25, 2024Osseointegration Problem; Osseointegration Problem
PROBLEM WITH OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20538303 ↗InjurySep 3, 2024Positioning Failure; Positioning Failure
InjuryAug 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20009096 ↗InjuryMay 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 12, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4) DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17922533 ↗InjuryAug 29, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17644622 ↗InjuryJun 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17188449 ↗InjuryJun 5, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17060842 ↗InjuryMar 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16610809 ↗InjuryDec 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15923118 ↗InjuryNov 24, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 15860388 ↗InjuryAug 29, 2022Positioning Failure; Positioning Failure
PER COMPLAINT 84390, DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 15311861 ↗InjuryJun 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4) DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14733402 ↗InjuryJun 10, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Granuloma; Inflammation; Unspecified Infection
MAUDE report 14654666 ↗InjuryJun 10, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14654658 ↗InjuryMar 23, 2022Osseointegration Problem; Osseointegration Problem
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 13860740 ↗InjuryMar 17, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Granuloma; Inflammation; Unspecified Infection
MAUDE report 13801139 ↗InjuryMar 17, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Granuloma; Inflammation; Unspecified Infection
MAUDE report 13801135 ↗InjuryMar 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 13758705 ↗InjuryFeb 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13568830 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192221. One submission often covers many models, so check the product and lot details in each record.
- Z-0197-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
- Z-0198-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
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 18, 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