simplyLegacy™ DRIVER HT2.0LGRecalls & 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
- 15
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10841307119814), received between May 9, 2019 and May 2, 2023 — classified as 10 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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
Device problems
- Fracture8
- Separation Failure5
- Material Deformation2
- Break1
- Defective Device1
- Entrapment of Device1
- Positioning Problem1
Patient problems
- Failure of Implant14
- No Consequences Or Impact To Patient2
- Bone Fracture(s)1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2023Defective Device; Defective Device
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Bone Fracture(s)
MAUDE report 16857035 ↗InjuryApr 26, 2023Separation Failure; Separation Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Failure of Implant
MAUDE report 16813841 ↗InjuryFeb 27, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16444973 ↗InjuryMar 15, 2022Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDRUE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 13771014 ↗InjuryNov 25, 2021Material Deformation; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 12874665 ↗InjuryNov 25, 2021Material Deformation; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 12874663 ↗InjuryJul 30, 2021Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURED WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 12252618 ↗MalfunctionApr 9, 2021Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 11641418 ↗MalfunctionDec 15, 2020Separation Failure; Separation Failure
PER (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Failure of Implant
MAUDE report 11012423 ↗MalfunctionNov 12, 2020Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 10828266 ↗MalfunctionOct 5, 2020Fracture; Separation Failure; Fracture; Separation Failure
PER (B)(4), DURING CLINICAL PROCEDURE, DRIVER BROKE INSIDE OF THE IMPLANT AND BROKEN OR FRACTURED COMPONENT IS EXPERIENCED.
Patient problems: Failure of Implant
MAUDE report 10625443 ↗InjuryOct 5, 2020Fracture; Separation Failure; Fracture; Separation Failure
PER (B)(4), DURING CLINICAL PROCEDURE, PRODUCT IS FRACTURED.
Patient problems: Failure of Implant
MAUDE report 10625439 ↗InjuryOct 5, 2020Fracture; Separation Failure; Fracture; Separation Failure
PER (B)(4), DURING CLINICAL PROCEDURE, PRODUCT IS FRACTURED.
Patient problems: Failure of Implant
MAUDE report 10625437 ↗InjurySep 18, 2019Fracture; Fracture
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9081632 ↗MalfunctionMay 9, 2019Break; Entrapment of Device; Break; Entrapment of Device
PER COMPLAINT (B)(4), A DRIVER TOOL BROKE INSIDE A DENTAL IMPLANT DURING INITIAL PLACEMENT. THE BROKEN PIECE WAS UNABLE TO BE REMOVED. THE IMPLANT WAS REMOVED AND REPLACED WITHIN THE SAME PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8597659 ↗
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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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