Legacy™2 Implant 823706Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 6 Platform 3.5mmD · Implant
All models of Legacy2 Implant (78)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Legacy2 Implant is a small screw-like dental implant used to anchor a replacement tooth in the jawbone. The 38 reports mostly describe the implant failing to fuse properly with the surrounding bone, so it does not become stable and may need to be removed, along with a few reports of the implant sitting in the wrong position. There are no deaths, and all 38 reports describe injuries; some also mention pain and inflammation. 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10841307101239), received between Sep 10, 2019 and Jun 12, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (28 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 Osseointegrate28
- Loss of Osseointegration5
- Positioning Problem3
- Osseointegration Problem2
Patient problems
- Failure of Implant34
- No Consequences Or Impact To Patient10
- Osteopenia/ Osteoporosis9
- Pain5
- Fibrosis3
- Inadequate Osseointegration3
- Inflammation3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 25487698 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483843 ↗InjuryNov 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20678752 ↗InjuryJan 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 29, 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; Osteopenia/ Osteoporosis
MAUDE report 17227072 ↗InjuryJul 25, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 15093360 ↗InjuryDec 27, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 13087909 ↗InjuryDec 21, 2021Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 13057612 ↗InjuryJul 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12196567 ↗InjuryJul 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Granuloma; Unspecified Infection
MAUDE report 12179733 ↗InjuryMar 31, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FRACTURE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 11595765 ↗InjuryDec 30, 2020Failure 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 11094554 ↗InjuryDec 22, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE,PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 11053389 ↗InjuryDec 22, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11053388 ↗InjuryNov 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE
Patient problems: Failure of Implant; Pain
MAUDE report 10874516 ↗InjurySep 29, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 10600225 ↗InjurySep 23, 2020Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 10573340 ↗InjuryMar 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9871153 ↗InjuryMar 11, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9817211 ↗InjuryMar 11, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9817205 ↗InjuryMar 11, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9816105 ↗InjuryMar 4, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 9784342 ↗InjuryFeb 27, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 9762301 ↗InjuryFeb 27, 2020Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9762259 ↗InjuryFeb 27, 2020Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9762256 ↗
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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