simply Legacy™3 Implant 855713URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of simply Legacy3 Implant (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307107972), received between Jun 29, 2023 and May 26, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K192221); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2
- Failure to Osseointegrate1
- No Apparent Adverse Event1
- Osseointegration Problem1
- Premature Separation1
Patient problems
- Inadequate Osseointegration3
- Failure of Implant2
- Unspecified Infection2
- Granuloma1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Granuloma; Inadequate Osseointegration
MAUDE report 25285522 ↗InjuryDec 15, 2025Loss of Osseointegration; Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23811041 ↗InjuryFeb 10, 2025Failure to Osseointegrate; No Apparent Adverse Event; Failure to Osseointegrate; No Apparent Adverse Event
FAILURE OF OSSEOINTEGRATION
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21350138 ↗InjuryNov 29, 2023Premature Separation; Premature Separation
InjuryJun 29, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17227069 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192221. One submission often covers many models, so check the product and lot details in each record.
- Z-0198-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- Z-0197-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
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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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