simplyLegacy™ DRIVER HD2.0SGRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307119913), received between Sep 14, 2021 and Jul 31, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (4 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.

• InjuryJul 31, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 17425217 ↗
• InjuryMay 16, 2023Defective Device; Defective Device

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

  Patient problems: Failure of Implant

  MAUDE report 16937017 ↗
• InjuryApr 14, 2022Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 14111032 ↗
• InjurySep 14, 2021Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 12466972 ↗
• InjurySep 14, 2021Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 12466953 ↗