N/A 68015191Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (M) long · Class 1
Quick summary
This Dentsply Implant Driver EV is an accessory tool used to place dental implants. Most of the 302 reports describe the driver fracturing or having mechanical problems. The reports include 3 injuries and no deaths, and no recalls name this device. The first report came in December 2025.
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
- 319
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 07392532254871), received between Dec 2, 2025 and Sep 29, 2026 — classified as 3 injuries, 316 malfunctions.
The most frequently reported specific device problem is “Fracture” (287 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
- Fracture287
- Mechanical Problem28
- Material Deformation2
- Insufficient Device Problem Information1
- Mechanical Jam1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions313
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 319 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
It was reported that there was a tool malfunction where the implant driver rubber tip broke. The surgery could be completed successfully.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934763 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934502 ↗MalfunctionSep 29, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934478 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934196 ↗MalfunctionSep 29, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931576 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926369 ↗MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925222 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923723 ↗MalfunctionSep 22, 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 50853736 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792303 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792278 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792236 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792198 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792127 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792043 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792037 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787617 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787592 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787459 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787363 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787319 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787117 ↗MalfunctionSep 15, 2026Mechanical Problem
It was reported that there was a malfunction where there was no engagement between the implant driver and implant fixtures.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772503 ↗MalfunctionSep 15, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771860 ↗MalfunctionSep 15, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771855 ↗
Other Accessories, implant, dental, endosseous devices
- N/A 68015189Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous388 reports
- N/A 68015193Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous283 reports
- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
- N/A 68015188Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous185 reports
- N/A 68015192Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous159 reports
- N/A 68015190Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous147 reports
- NobelReplace® 37045Nobel Biocare AB · Accessories, implant, dental, endosseous2 recalls0 reports
- N/A 68015195Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous93 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.