Legacy™1 Implant 815708Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 5.7mmD x 8mmL, 5.7mmD Platform · Class 2 · Implant
All models of Legacy1 Implant (27)
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 10841307101130), received between Sep 10, 2019 and Dec 17, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Positioning Problem” (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
- Positioning Problem2
- Failure to Osseointegrate1
- Osseointegration Problem1
Patient problems
- Failure of Implant4
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2020Osseointegration Problem; Osseointegration Problem
(B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11025871 ↗InjuryDec 17, 2020Positioning Problem; Positioning Problem
(B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 11025870 ↗InjuryDec 17, 2020Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 11025869 ↗InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK DOCTOR FOUND OUT THAT THE IMPLANT WAS MOBILE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 8979670 ↗
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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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