simply Legacy™3 Implant 857008URecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841307107996), received between Sep 19, 2019 and Nov 18, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration

  PRODUCT COMPL: LOSS OF OSSEOINTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 20713531 ↗
• InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326973 ↗
• InjuryAug 9, 2022Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4)., DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 15196482 ↗
• InjuryJun 7, 2022Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain; Unspecified Infection

  MAUDE report 14621408 ↗
• InjuryAug 25, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 12365105 ↗
• InjuryMay 26, 2021Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE PATIENT EXPERIENCED PRODUCT FAILURE.

  Patient problems: Failure of Implant

  MAUDE report 11884398 ↗
• InjuryJun 26, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER (B)(4), THE DENTAL IMPLANT FAILED TO INTEGRATE. PATIENT EXPERIENCED AN INFECTION AND BONE LOSS.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 10204080 ↗
• InjuryNov 28, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE,PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 9389832 ↗
• InjurySep 19, 2019Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY. LOSS OF BUCCAL PLATE WAS ALSO OBSERVED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9086004 ↗

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-0197-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
• Z-0198-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,