Legacy™4 Implant 884210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841307103318), received between Mar 27, 2019 and Nov 27, 2020 — classified as 5 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Wound Dehiscence

  MAUDE report 10912935 ↗
• InjuryNov 10, 2020Positioning Problem; Positioning Problem

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

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

  MAUDE report 10816571 ↗
• InjurySep 9, 2019Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT, IMPLANT CAME OUT AT HOME.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Pain

  MAUDE report 8976479 ↗
• InjurySep 6, 2019Failure to Osseointegrate; Failure to Osseointegrate

  AS PER COMPLAINT (B)(4), A DENTAL IMPLANT HAD A FAILURE OF INTEGRATION DURING A CLINICAL PROCEDURE AND THE IMPLANT WAS EXPLANTED. DELAYED HEALING AND INFLAMMATION WERE REPORTED.

  Patient problems: Failure of Implant; Impaired Healing; Inflammation; Swelling

  MAUDE report 8971485 ↗
• InjuryAug 28, 2019Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE IT WAS OBSERVED THAT PATIENT EXPERIENCED LOSS OF BONE, INFECTION AND LOSS OF INTEGRATION AFTER LOADING.

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

  MAUDE report 8938505 ↗
• MalfunctionMar 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PER COMPLAINT (B)(4), DURING THE CLINICAL PROCEDURE, UPON INSERTION OF THE IMPLANT, THE DRIVER WOULD NOT DISENGAGE FROM THE IMPLANT. THE IMPLANT REQUIRED BACKING OUT AND IT WAS SEPARATED FROM THE DRIVER WITH PLIERS.

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

  MAUDE report 8458563 ↗

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,