Legacy™4 Implant 874706Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.7 x 6 Platform 4.5mmD · Implant
All models of Legacy4 Implant (58)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307102953), received between Sep 10, 2019 and Jun 29, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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.
Most reported problems
Device problems
- Failure to Osseointegrate2
- Loss of Osseointegration1
- Positioning Failure1
Patient problems
- Failure of Implant4
- Granuloma1
- Inflammation1
- No Consequences Or Impact To Patient1
- No Information1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 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 17227054 ↗InjuryAug 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Granuloma; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 12342040 ↗InjuryApr 7, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Information
MAUDE report 9932639 ↗InjurySep 10, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), IMPLANT WAS PLACED 1 YEAR AGO, TWO BONE GRAFTING PROCEDURES WERE ALSO PERFORMED WHICH WERE UNSUCCESSFUL. IMPLANT ON #5 WAS REMOVED. AN IMPLANT WAS PLACED IN AREA OF #6, THEN IMMEDIATELY REMOVED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8979568 ↗
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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