Legacy™4 Implant 877010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841307103158), received between Aug 27, 2019 and Mar 17, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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.

• InjuryMar 17, 2023Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Hypersensitivity/Allergic reaction; Numbness

  MAUDE report 16564717 ↗
• InjuryMay 24, 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; Insufficient Information

  MAUDE report 14489050 ↗
• InjuryMar 9, 2022Failure to Osseointegrate; Failure to Osseointegrate

  PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 13717262 ↗
• InjuryMar 26, 2021Osseointegration Problem; Osseointegration Problem

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

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

  MAUDE report 11574151 ↗
• InjuryOct 8, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis; Sinus Perforation

  MAUDE report 10649041 ↗
• InjuryFeb 27, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis

  MAUDE report 9761779 ↗
• InjuryDec 27, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 9522892 ↗
• InjuryDec 18, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis

  MAUDE report 9487335 ↗
• InjuryAug 27, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. THERE WERE NO ADVERSE EVENTS NOTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 8937941 ↗

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