simplyLegacy™ DRIVER HT3.0LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10841307119890), received between Oct 28, 2018 and Jun 1, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2023Defective Device; Defective Device

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 17037407 ↗
• InjuryDec 1, 2022Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.

  Patient problems: Failure of Implant

  MAUDE report 15896394 ↗
• InjuryAug 10, 2021Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12300171 ↗
• InjuryAug 4, 2020Separation Failure; Separation Failure

  AS PER COMPLAINT (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANTS COMPONENTS COULD NOT BE SEPARATED AND THE IMPLANT WAS REMOVED. THERE WAS 1 PATIENT INVOLVED IN THIS EVENT.

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

  MAUDE report 10363968 ↗
• MalfunctionMar 26, 2020Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, ORING PORTION OF DRIVER LODGED INTO IMPLANT.

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

  MAUDE report 9882172 ↗
• MalfunctionFeb 14, 2020Defective Component; Defective Component

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, 3.0 DRIVER WELDED INTO THE PLATFORM OF IMPLANT. IMPLANT WAS REMOVED AND DRIVER WAS STILL STUCK.

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

  MAUDE report 9710746 ↗
• MalfunctionMay 8, 2019Device Damaged by Another Device; Device Damaged by Another Device

  PER COMPLAINT (B)(4), DURING THE CLINICAL PROCEDURE, THE IMPLANT AND DRIVER KNUCKLED. THE IMPLANT WAS REMOVED AND A NEW ONE WAS PLACED. PER THE COMPLAINT, THE PROCEDURE WAS COMPLETED IN THE SAME VISIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593261 ↗
• MalfunctionOct 28, 2018Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), DURING IMPLANT PLACEMENT UNDER IV SEDATION, THE DRIVER WOULD NOT DETACH FROM THE IMPLANT. THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT.

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

  MAUDE report 8011526 ↗