Legacy™1 Implant 814711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.7mmD x 11.5mmL, 4.5mmD Platform · Class 2 · Implant
All models of Legacy1 Implant (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 10841307101109), received between Aug 5, 2019 and Mar 9, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Loss of Osseointegration2
Patient problems
- Failure of Implant2
- Osteopenia/ Osteoporosis2
- Fibrosis1
- Inflammation1
- Organ Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE
Patient problems: Failure of Implant; Fibrosis; Organ Dehiscence; Osteopenia/ Osteoporosis
MAUDE report 11445911 ↗InjuryAug 5, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), WHEN ABUTMENT SCREWS WAS REMOVED ON #12 IMPLANT THE #13 AND #14 IMPLANTS FELL OUT. PATIENT EXPERIENCED EMOTIONAL WITH LOSS OF TWO IMPLANTS.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 8862604 ↗
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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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