simplyLegacy™ DRIVER HT3.0SGRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
All models of simplyLegacy DRIVER (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307119906), received between Oct 14, 2020 and Jun 1, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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 18, 2026.
Most reported problems
Device problems
- Defective Device1
- Fracture1
- Separation Failure1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 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 17037378 ↗InjuryMay 30, 2023Separation Failure; Separation Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPRATED.
Patient problems: Failure of Implant
MAUDE report 17024800 ↗MalfunctionOct 14, 2020Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DRIVER FRACTURED, AND STUCK INSIDE THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 10678121 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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