N/A 68015187Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (XS) long · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Implant Driver EV is a driver tool used to place dental implants. Its 252 reports often describe the driver breaking, with no injuries and no deaths reported. Reports rose from 0 in the previous 12 months to 252 in the most recent 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
- 266
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 266 adverse event reports that list this exact device (DI 07392532254833), received between Dec 16, 2025 and Sep 30, 2026 — classified as 266 malfunctions.
The most frequently reported specific device problem is “Fracture” (252 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
- Fracture252
- Mechanical Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions263
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 266 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 50951391 ↗MalfunctionSep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951026 ↗MalfunctionSep 28, 2026Fracture
It was reported there was a tool malfunction; no injury resulted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923854 ↗MalfunctionSep 22, 2026Mechanical Problem
It was reported there was a tool issue; the implant didn't engage in implant driver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858614 ↗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 50853283 ↗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 50791897 ↗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 50791895 ↗MalfunctionSep 16, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791886 ↗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 50791882 ↗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 50788942 ↗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 50788811 ↗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 50788554 ↗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 50787729 ↗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 50772017 ↗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 50772015 ↗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 50771788 ↗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 50771777 ↗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 50771733 ↗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 50731181 ↗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 50731176 ↗MalfunctionSep 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703235 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702998 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702844 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667572 ↗MalfunctionJul 15, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825431 ↗
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 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page