simplyLegacy™ DRIVER HD2.5SGRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307119937), received between May 14, 2022 and Aug 28, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2023Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, DRIVER GOT STUCK IN THE HAND PIECE.

  Patient problems: Failure of Implant

  MAUDE report 17630811 ↗
• InjuryMar 1, 2023Material Deformation; Material Deformation

  PER COMPLAINT (B)(4) DURING CLINICAL PROCEDURE, DEFORMATION WAS OBSERVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16460651 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 16377874 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 16377865 ↗
• InjuryMay 14, 2022Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS A BROKEN/FRACTURED COMPONENT.

  Patient problems: Failure of Implant

  MAUDE report 14403642 ↗