N/A 68015192Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (L) short · Class 1
Quick summary
This Dentsply implant driver has 146 FDA adverse event reports, with no deaths and 2 injuries. Most describe the tool fracturing, and a few mention a drill bit sticking in an extension. Reports jumped to 145 in the latest 12 months from 1 in the 12 months before. 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
- 159
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 07392532254888), received between May 21, 2025 and Sep 30, 2026 — classified as 2 injuries, 157 malfunctions.
The most frequently reported specific device problem is “Fracture” (146 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
- Fracture146
- Mechanical Problem12
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions158
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 159 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 50951631 ↗MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926523 ↗MalfunctionSep 28, 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 50917909 ↗MalfunctionSep 28, 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 50917898 ↗MalfunctionSep 22, 2026Fracture
It was reported there was a tool issue; Primetaper Pick-UP drill was broken while doing surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857189 ↗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 50853992 ↗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 50788609 ↗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 50787934 ↗MalfunctionSep 11, 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 50730926 ↗MalfunctionSep 11, 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 50730925 ↗MalfunctionSep 11, 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 50730891 ↗MalfunctionSep 11, 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 50730890 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702924 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667487 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667483 ↗MalfunctionSep 8, 2026Fracture
It was reported that there was a tool malfunction where the implant driver PEEK tip broke. Surgery was successfully completed with another tool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667481 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667424 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667418 ↗MalfunctionAug 11, 2026Fracture
It was reported an implant driver peek broke; no injury resulted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208287 ↗MalfunctionJul 15, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25826372 ↗MalfunctionJul 14, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816760 ↗MalfunctionJul 14, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815420 ↗MalfunctionJul 14, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815223 ↗MalfunctionJul 14, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812158 ↗MalfunctionJul 13, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25804341 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.