Legacy™4 Implant 875206Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 6 Platform 4.5mmD · Implant
All models of Legacy4 Implant (58)
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 10841307103011), received between Sep 10, 2019 and Apr 26, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Osseointegration 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
- Osseointegration Problem2
- Failure to Osseointegrate1
- Positioning Failure1
Patient problems
- Failure of Implant4
- Pain2
- Edema1
- Inflammation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 14208347 ↗InjuryMar 31, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS AN ERROR IN SURGICAL PROTOCOL.
Patient problems: Failure of Implant
MAUDE report 13966531 ↗InjuryNov 19, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING THE REMOVAL OF ABUTMENT, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE
Patient problems: Failure of Implant; Pain
MAUDE report 10867268 ↗InjurySep 10, 2019Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE DUE TO ERROR IN SURGICAL PROTOCOL.
Patient problems: Edema; Failure of Implant; Inflammation; Pain
MAUDE report 8979514 ↗
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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