Legacy™3 Implant 865706Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 5.7mmD x 6mmL, 5.7mmD Platform · Implant
All models of Legacy3 Implant (75)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307102670), received between Dec 11, 2019 and Apr 8, 2021 — classified as 7 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (4 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
- Loss of Osseointegration4
- Failure to Osseointegrate3
Patient problems
- Failure of Implant7
- Osteopenia/ Osteoporosis3
- Impaired Healing1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11632530 ↗InjuryJan 20, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 11200421 ↗InjuryJan 19, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 11191811 ↗InjuryNov 25, 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
MAUDE report 10904213 ↗InjuryNov 19, 2020Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 10867229 ↗InjuryApr 17, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 9971671 ↗InjuryDec 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9454353 ↗
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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