N/A 68015195Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (XL) long · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply implant driver is a dental tool used to place implants. Its 88 reports mostly describe the driver fracturing, with some describing loss of grip. The reports include no deaths and no injuries. Reports rose from 0 in the prior 12 months to 88 in the last 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
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 07392532254918), received between Dec 16, 2025 and Sep 22, 2026 — classified as 93 malfunctions.
The most frequently reported specific device problem is “Fracture” (83 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture83
- Mechanical Problem7
- Insufficient Device Problem Information3
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
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 50858238 ↗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 50854535 ↗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 50771893 ↗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 50771881 ↗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 50731122 ↗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 50667906 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667265 ↗MalfunctionJul 14, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER NO LONGER HAS RETENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815408 ↗MalfunctionJul 14, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815395 ↗MalfunctionJul 14, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815341 ↗MalfunctionJul 14, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 25813244 ↗MalfunctionJul 13, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25804392 ↗MalfunctionJul 13, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25797889 ↗MalfunctionJul 1, 2026Fracture
IT WAS REPORTED THAT DURING THE DISINFECTION PROCESS AND USE OF THE EV SURGICAL TOOL KIT, SOME OF THE DRIVERS WERE DAMAGED, AFFECTING THE PROGRESS OF THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25681604 ↗MalfunctionJun 26, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633627 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE IMPLANT DRIVER BROKE WHILE BEING USED WITH A RESTORATIVE DRIVER HANDLE. NO INJURIES WERE REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25342146 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER IS BROKEN AND CANNOT GET STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329791 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER IS BROKEN AND CANNOT GET STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329519 ↗MalfunctionMay 28, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317486 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302613 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301819 ↗MalfunctionMay 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 25295420 ↗MalfunctionMay 12, 2026Fracture
IT WAS REPORTED A TOOL ISSUE WITH PROGRESSIVE BONE LOSS, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25156366 ↗MalfunctionMay 8, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122893 ↗MalfunctionMay 7, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116858 ↗
Other Accessories, implant, dental, endosseous devices
- N/A 68015189Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous388 reports
- N/A 68015191Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous319 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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