N/A 68015190Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (M) short · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply implant driver, a dental accessory, has 132 reports, most describing the driver breaking. The reports mention no deaths or injuries, and no recalls name this device. Reports rose to 132 in the last 12 months from 0 in the previous 12.
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
- 147
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 07392532254864), received between Dec 19, 2025 and Sep 28, 2026 — classified as 147 malfunctions.
The most frequently reported specific device problem is “Fracture” (133 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
- Fracture133
- Mechanical Problem12
- Mechanical Jam1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions147
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925877 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923233 ↗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 50853598 ↗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 50792015 ↗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 50792003 ↗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 50788593 ↗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 50787814 ↗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 50772433 ↗MalfunctionSep 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731134 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703220 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703203 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703098 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702981 ↗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 50667639 ↗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 50667636 ↗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 50667634 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667620 ↗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 50667615 ↗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 50667611 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667314 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667297 ↗MalfunctionJul 16, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25843367 ↗MalfunctionJul 16, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE IMPLANT DRIVER COULD NOT BE SEPARATED FROM HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25837301 ↗MalfunctionJul 15, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825646 ↗MalfunctionJul 13, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805546 ↗
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
- 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.
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