N/A 68015189Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (S) long · Class 1
Quick summary
This Dentsply Implant Driver EV is a hand tool used to place dental implants. Its 380 reports mostly describe the driver fracturing, and a few mention other mechanical problems. The reports include 8 injuries and no deaths. All 380 reports came in the last 12 months, and none came in the previous 12 months. No recalls name 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
- 388
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 388 adverse event reports that list this exact device (DI 07392532254857), received between Dec 15, 2025 and Sep 30, 2026 — classified as 8 injuries, 380 malfunctions.
The most frequently reported specific device problem is “Fracture” (369 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
- Fracture369
- Mechanical Problem18
- Damaged Thread1
- Off-Label Use1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions381
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Failure of Implant3
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 388 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951578 ↗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 50934425 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934370 ↗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 50858174 ↗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 50853500 ↗MalfunctionSep 22, 2026Fracture
It was reported that the PEEK plastic tip broke off the driver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849562 ↗MalfunctionSep 21, 2026Fracture
It was reported that there was a tool malfunction where the implant driver tip broke. The surgery could be completed successfully with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845680 ↗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 50791981 ↗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 50791967 ↗MalfunctionSep 16, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791965 ↗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 50788480 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver does not hold the implant due to a broken tip.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788057 ↗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 50787867 ↗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 50787744 ↗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 50787545 ↗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 50787541 ↗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 50787438 ↗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 50787304 ↗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 50786823 ↗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 50772369 ↗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 50772147 ↗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 50772067 ↗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 50771812 ↗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 50771806 ↗MalfunctionSep 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731051 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.