Legacy™3 Implant 855206Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 6 Platform 4.5mmD · Implant
All models of Legacy3 Implant (75)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Legacy3 Implant from Implant Direct is a small screw-shaped dental implant used to anchor a replacement tooth in the jawbone. The 31 reports describe the implant failing to fuse with the surrounding bone, so it becomes loose or has to be removed, along with pain, swelling, and a few cases where the implant or jaw bone fractured. No deaths were reported and all 31 reports involved an injury. No recalls name this device, and no reports were filed in the past 12 months.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10841307102212), received between Apr 5, 2019 and Nov 19, 2024 — classified as 31 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 Osseointegrate17
- Loss of Osseointegration4
- Osseointegration Problem4
- Positioning Problem3
- Fracture2
- Patient Device Interaction Problem2
- Positioning Failure1
Patient problems
- Failure of Implant29
- Pain11
- No Consequences Or Impact To Patient7
- Osteopenia/ Osteoporosis7
- Edema4
- Foreign Body Reaction2
- Inadequate Osseointegration2
- Inflammation2
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20719819 ↗InjuryApr 4, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 23, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 15275515 ↗InjuryOct 4, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FIT WAS OBSERVED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12567422 ↗InjurySep 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12421177 ↗InjuryApr 29, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 11743784 ↗InjuryJan 6, 2021Failure 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; Pain
MAUDE report 11121923 ↗InjuryDec 24, 2020Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 11071014 ↗InjuryNov 24, 2020Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 10895874 ↗InjuryApr 3, 2020Osseointegration Problem; Osseointegration Problem
PER (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Edema; Failure of Implant; Pain
MAUDE report 9920078 ↗InjuryApr 2, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9914834 ↗InjuryMar 31, 2020Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9902359 ↗InjuryMar 26, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 9882171 ↗InjuryMar 3, 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; Pain
MAUDE report 9778701 ↗InjuryDec 26, 2019Failure 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 9518239 ↗InjuryDec 26, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Edema; Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9518222 ↗InjuryNov 30, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OR LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9392134 ↗InjuryNov 30, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 9392126 ↗InjuryNov 30, 2019Failure 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; No Consequences Or Impact To Patient
MAUDE report 9392124 ↗InjurySep 30, 2019Fracture; Fracture
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FRACTURE OF VESTIBULE DURING PLACEMENT.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9133572 ↗InjurySep 13, 2019Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), IT WAS OBSERVED THAT PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9022220 ↗InjurySep 12, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF BONE INTEGRATION, 3-4 MONTHS AFTER THE FIRST SURGERY.
Patient problems: Failure of Implant; No Information
MAUDE report 9003545 ↗InjurySep 12, 2019Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), IT WAS FOUND THAT THE IMPLANT DID NOT ENGAGED DURING PLACEMENT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9003531 ↗InjurySep 12, 2019Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), IT WAS FOUND THAT THE IMPLANT DID NOT ENGAGED DURING PLACEMENT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9003530 ↗InjurySep 11, 2019Osseointegration Problem; Osseointegration Problem
AS PER COMPLAINT (B)(4), A DENTAL IMPLANT HAD A PROBLEM WITH OSSEOINTEGRATION AND THE IMPLANT WAS REMOVED. PAIN WAS RECORDED.
Patient problems: Failure of Implant; Pain
MAUDE report 8995902 ↗
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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