Legacy™1 Implant 814213Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.2mmD x 13mmL, 3.5mmD Platform · Class 2 · Implant
All models of Legacy1 Implant (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307101062), received between Oct 12, 2020 and Dec 2, 2020 — classified as 3 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
Patient problems
- Failure of Implant3
- Granuloma2
- Inflammation2
- Unspecified Infection2
- Fistula1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 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; Granuloma; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 10934433 ↗InjuryNov 27, 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; Granuloma; Inflammation; Unspecified Infection
MAUDE report 10912945 ↗InjuryOct 12, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PRODUCT MALFUNCTION IS EXPERIENCED.
Patient problems: Failure of Implant; Fistula
MAUDE report 10662689 ↗
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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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