simplyLegacy DRIVERRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 0
We found 8 models of simplyLegacy DRIVER by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2018 and Aug 14, 2024 — classified as 40 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Fracture” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported simplyLegacy DRIVER problems
Device problems
- Fracture28
- Separation Failure17
- Defective Device5
- Material Deformation5
- Osseointegration Problem4
- Break3
- Positioning Failure3
- Positioning Problem3
Patient problems
- Failure of Implant58
- No Consequences Or Impact To Patient15
- Insufficient Information3
- No Information3
- Bone Fracture(s)2
- Unspecified Infection2
- Discomfort1
- No Clinical Signs, Symptoms or Conditions1
simplyLegacy DRIVER models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- simplyLegacy™ DRIVER HT2.0LGAccessories, Implant, Dental, Endosseous15 reports
- simplyLegacy™ DRIVER HT2.0SGAccessories, Implant, Dental, Endosseous15 reports
- simplyLegacy™ DRIVER HT2.5LGAccessories, Implant, Dental, Endosseous15 reports
- simplyLegacy™ DRIVER HT3.0LGAccessories, Implant, Dental, Endosseous8 reports
- simplyLegacy™ DRIVER HD2.0SGAccessories, Implant, Dental, Endosseous5 reports
- simplyLegacy™ DRIVER HD2.5SGAccessories, Implant, Dental, Endosseous5 reports
- simplyLegacy™ DRIVER HT2.5SGAccessories, Implant, Dental, Endosseous3 reports
- simplyLegacy™ DRIVER HT3.0SGAccessories, Implant, Dental, Endosseous3 reports
Recent simplyLegacy DRIVER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Fracture; Fracture
BROKEN / FRACTURED COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19984660 ↗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 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 ↗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 ↗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 ↗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 17037407 ↗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 ↗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 ↗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 ↗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 16854791 ↗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 ↗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 ↗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 ↗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 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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