Legacy™3 Implant 864706Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.7mmD x 6mmL, 4.5mmD Platform · Implant
All models of Legacy3 Implant (75)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307102557), received between Oct 9, 2019 and Nov 7, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).
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 Osseointegration1
- Positioning Failure1
Patient problems
- Failure of Implant2
- Impaired Healing1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2021Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, ERROR IN SURGICAL PROTOCOL.
Patient problems: Failure of Implant
MAUDE report 12756859 ↗InjuryOct 9, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER PROSTHETIC TREATMENT, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing; Osteopenia/ Osteoporosis
MAUDE report 9171385 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page