DS Implants 68017001Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (S) ND GS · Class 1
Quick summary
This Dentsply Implant Driver is a surgical tool used to place dental implants. The 36 adverse event reports mostly describe the driver tip breaking or deforming during use, and in several cases a dental implant itself fracturing in the patient; 6 reports involve injuries and none describe a death. Most reports mention no lasting harm to the patient. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07392532268977), received between Nov 18, 2025 and Sep 29, 2026 — classified as 5 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (26 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
- Fracture26
- Mechanical Problem6
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Failure of Implant3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934300 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889915 ↗MalfunctionSep 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820736 ↗MalfunctionSep 9, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50690738 ↗InjuryAug 6, 2026Fracture
It was reported that the implant driver tip fractured, allegedly resulting in abortion of the surgery.
Patient problems: Failure of Implant
MAUDE report 50158307 ↗InjuryJul 29, 2026Fracture
It was reported that a patient experienced a dental implant fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50067217 ↗MalfunctionJun 9, 2026Fracture
IT WAS REPORTED THERE WAS A TOOL ISSUE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442906 ↗MalfunctionJun 9, 2026Fracture
IT WAS REPORTED THERE WAS A TOOL ISSUE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442773 ↗MalfunctionJun 7, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE PLASTIC TIP OF THE GS DRIVER BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25421140 ↗MalfunctionJun 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE PEEK PLASTIC BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364426 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310647 ↗MalfunctionMay 17, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER FRACTURED; NO INJURY RESULTED. SESSION COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196345 ↗MalfunctionMay 7, 2026Mechanical Problem
CUSTOMER REPORTED THE TOOL ISSUE: THE METAL IMPLANT DRIVER CAN NOT STUCK TO THE IMPLANT, RESULTING IN THE IMPLANT FALLING OFF DURING THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117687 ↗MalfunctionMay 7, 2026Mechanical Problem
CUSTOMER REPORTED THE TOOL ISSUE: THE METAL IMPLANT DRIVER CAN NOT STUCK TO THE IMPLANT, RESULTING IN THE IMPLANT FALLING OFF DURING THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116700 ↗MalfunctionApr 26, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993548 ↗MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEAK TIP BROKE DURING USE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956805 ↗MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEAK TIP BROKE DURING USE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956625 ↗InjuryApr 13, 2026Fracture
IT WAS REPORTED, THAT AN IMPLANT DRIVER FRACTURED AND LED TO THE ABORTION OF A SURGERY.
Patient problems: Failure of Implant
MAUDE report 24859384 ↗MalfunctionMar 30, 2026Fracture
CUSTOMER REPORTED THE FRACTURE OF AN IMPLANT DRIVER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735386 ↗MalfunctionMar 30, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER PEEK WAS BROKEN. NO PATIENT INVOLVEMENT. TREATMENT WAS COMPLETED WITH NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716525 ↗MalfunctionMar 30, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714623 ↗InjuryMar 30, 2026Mechanical Problem
CUSTOMER REPORTED IMPLANT DRIVER DOESN'T ENGAGE INTO IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713913 ↗MalfunctionMar 25, 2026Fracture
CUSTOMER REPORTED FOURFOLD BROKEN IMPLANT DRIVER TIPS. THE PROCEDURE HAS BEEN COMPLETED. DRIVERS USED ACCORDING TO PROCEDURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689317 ↗MalfunctionMar 25, 2026Fracture
CUSTOMER REPORTED THE FRACTURE OF AN IMPLANT DRIVER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687620 ↗MalfunctionMar 24, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681014 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.