Legacy™3 Implant 857006Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø7.0 x 6 Platform 5.7mmD · Implant
All models of Legacy3 Implant (75)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307102335), received between Mar 1, 2019 and Nov 18, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 Osseointegrate3
- Fracture1
- Material Deformation1
- Separation Failure1
Patient problems
- Failure of Implant4
- Fibrosis1
- Granuloma1
- Inadequate Osseointegration1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Wound Dehiscence1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20717567 ↗InjuryJun 30, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BONE FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 17237295 ↗InjuryOct 18, 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; Fibrosis; Granuloma; Inflammation; Wound Dehiscence
MAUDE report 15626906 ↗InjuryNov 27, 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 10912924 ↗MalfunctionMar 1, 2019Separation Failure; Material Deformation; Separation Failure; Material Deformation
PER COMPLAINT (B)(4), THE COPING WAS UNABLE TO BE REMOVED DURING DENTAL IMPLANT PLACEMENT. THE COPING STRIPPED AND THE DRIVER WAS UNABLE TO BE PLACED. THE IMPLANT WAS EXPLANTED ON THE SAME DAY. NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8383838 ↗
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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