N/A 68015194Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (XL) short · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Implant Driver EV (XL) short is a hand tool used to place dental implants. The 49 reports all describe the driver breaking, cracking or deforming, sometimes during cleaning or when used with a restorative driver handle, and once sticking to its extender during implant placement, which slowed surgery. No deaths or injuries were reported, and 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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 07392532254901), received between Dec 16, 2025 and Sep 30, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Fracture” (51 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
- Fracture51
- Mechanical Problem3
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions56
Recent adverse event reports
The 25 most recent of 56 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 50951904 ↗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 50854284 ↗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 50792408 ↗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 50792395 ↗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 50730978 ↗MalfunctionSep 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703258 ↗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 50667814 ↗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 50667808 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667087 ↗MalfunctionJul 14, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812260 ↗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 25681652 ↗MalfunctionJun 26, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633671 ↗MalfunctionJun 23, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A IMPLANT DRIVER FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592613 ↗MalfunctionJun 19, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER AND EXTENDER GOT STUCK DURING IMPLANT PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563791 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342103 ↗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 25329325 ↗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 25329227 ↗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 25329127 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310712 ↗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 25295417 ↗MalfunctionMay 8, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122616 ↗MalfunctionMay 7, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116838 ↗MalfunctionMay 7, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116629 ↗MalfunctionApr 23, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973884 ↗MalfunctionApr 21, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938242 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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