simplyLegacy™ DRIVER HT2.5SGRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307119869), received between Mar 15, 2019 and Jan 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 13336801 ↗
• MalfunctionJun 7, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PER COMPLAINT (B)(4), THE IMPLANT DRIVER IS TOO RETENTIVE. THE CLINICIAN HAS TO HOLD THE CARRIER WITH RONGEURS TO REMOVE THE MOUNT. WHEN PLACING THE DRIVER DIRECTLY IN THE IMPLANT, THE IMPLANT COMES OUT WHEN TOOL REMOVAL IS ATTEMPTED. IN SOFT BONE, THE IMPLANT PULLS OUT. ADDITIONALLY, PER THE COMPLAINT, THE COLOR CODING ON THE TOOLS HAS WORN OUT.

  Patient problems: No Information

  MAUDE report 8679971 ↗
• MalfunctionMar 15, 2019Separation Failure; Material Deformation; Separation Failure; Material Deformation

  PER COMPLAINT (B)(4), A DRIVER COULD NOT BE REMOVED FROM THE DENTAL IMPLANT TRANSFER DURING INITIAL PLACEMENT. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW ONE WITHIN THE SAME VISIT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 8425228 ↗