simplyLegacy™ DRIVER HT2.0SGRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
- 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 10841307119821), received between May 31, 2019 and Aug 14, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture8
- Break2
- Osseointegration Problem2
- Separation Failure2
- Defective Device1
- Positioning Problem1
Patient problems
- Failure of Implant12
- No Consequences Or Impact To Patient5
- Bone Fracture(s)1
- Discomfort1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 15 most recent of 15 reports, 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 ↗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 ↗InjuryFeb 15, 2023Fracture; Fracture
PER COMPLAINT (B)(4) DURING CLINICAL PROCEDURE, BROKEN/FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Discomfort; Failure of Implant
MAUDE report 16377862 ↗InjuryJun 10, 2022Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14654661 ↗InjuryMar 2, 2022Osseointegration Problem; Osseointegration Problem
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 13657223 ↗InjuryDec 29, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 13108065 ↗InjuryJun 29, 2021Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENT COULD NOT BE SEPERATED.
Patient problems: Failure of Implant
MAUDE report 12083837 ↗MalfunctionNov 12, 2020Positioning Problem; Positioning Problem
PER (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 10828256 ↗InjuryOct 9, 2020Fracture; Separation Failure; Fracture; Separation Failure
PER COMPLAINT (B)(4), DRIVER BROKEN IN IMPLANT AFTER PLACEMENT.
Patient problems: Failure of Implant
MAUDE report 10654848 ↗MalfunctionAug 12, 2020Separation Failure; Separation Failure
AS PER COMPLAINT (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANTS ACCESSORY COULD NOT BE SEPERATED FROM THE IMPLANT AND THE IMPLANT WAS REMOVED. THERE WAS 1 PATIENT INVOLVED IN THIS EVENT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 10398472 ↗InjuryFeb 14, 2020Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DRIVER BROKE OFF IN THE IMPLANT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9710738 ↗MalfunctionJul 26, 2019Break; Break
PER COMPLAINT (B)(4), A HEX TOOL BROKE OFF WITHIN A DENTAL IMPLANT DURING CLINICAL PROCEDURE. THE IMPLANT WAS ALSO DAMAGED. THE IMPLANT WAS EXPLANTED. THE PROCEDURE WAS COMPLETED WITHIN THE SAME VISIT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8834165 ↗InjuryJul 25, 2019Break; Break
PER COMPLAINT (B)(4), A DENTAL IMPLANT DRIVER'S TIP SNAPPED DURING INITIAL PLACEMENT. THE PROCEDURE WAS NOT COMPLETED WITHIN THE SAME VISIT. NO ADDITIONAL ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8828278 ↗MalfunctionJul 12, 2019Fracture; Fracture
PER COMPLAINT (B)(4), A HEX TOOL FRACTURED WITHIN A DENTAL IMPLANT DURING CLINICAL PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 8787228 ↗InjuryMay 31, 2019Fracture; Fracture
PER COMPLAINT (B)(4), A DENTAL IMPLANT WAS INSERTED INTO A PATIENT'S MOUTH, BUT WAS NOT FULLY SEATED. IMPLANT REMOVAL WAS ATTEMPTED WITH HEX WRENCH DRIVER, BUT THE DRIVER FRACTURED WITHIN THE IMPLANT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8658814 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.