Legacy™2 Implant 824706Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.7 x 6 Platform 4.5mmD · Implant
All models of Legacy2 Implant (78)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10841307101352), received between Sep 17, 2019 and Mar 2, 2026 — classified as 23 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 Osseointegration3
- Osseointegration Problem2
- Positioning Problem1
Patient problems
- Failure of Implant19
- Inadequate Osseointegration4
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient4
- Pain4
- Inflammation3
- Osteopenia/ Osteoporosis2
- Unspecified Infection2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24491903 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483825 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21530320 ↗InjuryAug 9, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19950898 ↗InjuryMay 10, 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; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 16900992 ↗InjuryOct 12, 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; Osteopenia/ Osteoporosis; Pain
MAUDE report 15589307 ↗InjuryAug 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLNICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 15146516 ↗InjuryJul 18, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15042249 ↗InjuryFeb 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11341382 ↗InjuryFeb 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 11285533 ↗InjuryDec 17, 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 11025847 ↗InjuryDec 15, 2020Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 11012388 ↗InjuryDec 11, 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 10992018 ↗InjuryNov 13, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 10834869 ↗InjuryNov 4, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 10785011 ↗InjuryJul 20, 2020Positioning Problem; Positioning Problem
AS PER COMPLAINT (B)(4) A DENTAL IMPLANT DISPLAYED A LACK OF PRIMARY STABILITY AND THE IMPLANT WAS REMOVED. THIS EVENT INVOLVED 1 PATIENT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 10298275 ↗InjuryJul 17, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. PATIENT EXPERIENCED NO INJURIES..
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 10292950 ↗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; Pain
MAUDE report 9817151 ↗InjuryMar 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9809620 ↗InjuryNov 30, 2019Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4) DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9392155 ↗InjurySep 17, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9075278 ↗
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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