simplyLegacy™ DRIVER HT2.5LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10841307119852), received between Aug 21, 2018 and Oct 6, 2023 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2023Separation Failure; Separation Failure

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 17884455 ↗
• InjuryAug 23, 2023Separation Failure; Separation Failure

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

  Patient problems: Failure of Implant

  MAUDE report 17602169 ↗
• InjuryMar 3, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 16477255 ↗
• InjuryDec 1, 2022Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 15897498 ↗
• MalfunctionDec 9, 2021Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 12968700 ↗
• MalfunctionJul 27, 2021Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 12232540 ↗
• MalfunctionMay 25, 2021Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 11877189 ↗
• InjuryFeb 12, 2021Separation Failure; Osseointegration Problem; Separation Failure; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 11321430 ↗
• MalfunctionDec 9, 2020Material Deformation; Material Deformation

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

  Patient problems: Unspecified Infection

  MAUDE report 10973638 ↗
• MalfunctionNov 4, 2020Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), INSERTION TOOL WOULD NOT DETACH FROM IMPLANT AFTER PLACING. IMPLANT HAD TO BE BACKED OUT AND ANOTHER ONE PLACED.

  Patient problems: Insufficient Information

  MAUDE report 10785005 ↗
• MalfunctionOct 15, 2019Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), DRIVER GOT STUCK IN IMPLANT AND COULD NOT REMOVED FROM IMPLANT.

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

  MAUDE report 9190237 ↗
• MalfunctionOct 15, 2019Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), DRIVER GOT STUCK IN THE IMPLANT AND COULD NOT BE REMOVED.

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

  MAUDE report 9190232 ↗
• 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 WON OUT.

  Patient problems: No Information

  MAUDE report 8679961 ↗
• MalfunctionMay 17, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PER COMPLAINT (B)(4), THE PURPLE AND GREEN STRIPES ON A HEX WRENCH IMPLANT DRIVER WERE NOTED TO BE REMOVED AFTER AUTOCLAVING THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8621983 ↗
• MalfunctionAug 21, 2018Separation Problem; Separation Problem

  PER COMPLAINT (B)(4), THE HT2.5 TOOL BECAME STUCK IN THE IMPLANT. THIS RESULTED IN THE REMOVAL OF THE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801814 ↗