N/A 68015193Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (L) long · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Implant Driver EV long is a tool used to place dental implants into the jawbone. Of its 279 reports, 272 are malfunction reports, mostly describing the driver breaking or fracturing, and 7 are injury reports, some describing dental implant loss or failure. Reports rose from none in the previous 12 months to 279 in the last 12 months. There were no deaths, 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
- 283
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 283 adverse event reports that list this exact device (DI 07392532254895), received between Dec 12, 2025 and Sep 29, 2026 — classified as 7 injuries, 276 malfunctions.
The most frequently reported specific device problem is “Fracture” (253 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
- Fracture253
- Mechanical Problem21
- Failure to Osseointegrate2
- Insufficient Device Problem Information2
- Material Deformation2
- Off-Label Use2
- Separation Failure2
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions279
- Failure of Implant4
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 283 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936051 ↗MalfunctionSep 29, 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 50934390 ↗MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926578 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889769 ↗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 50854180 ↗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 50792352 ↗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 50792342 ↗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 50792332 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788398 ↗MalfunctionSep 16, 2026Fracture
It was reported that there was a tool malfunction where the implant driver tip broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788137 ↗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 50787707 ↗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 50787499 ↗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 50787149 ↗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 50731236 ↗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 50730732 ↗MalfunctionSep 10, 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 50703718 ↗MalfunctionSep 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703253 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703156 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702777 ↗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 50667748 ↗InjuryAug 13, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50230583 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant failure. Bone loss was also reported.
Patient problems: Failure of Implant
MAUDE report 50216802 ↗MalfunctionJul 16, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE TIP OF AN IMPLANT DRIVER FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25837597 ↗MalfunctionJul 15, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825524 ↗MalfunctionJul 14, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816724 ↗
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 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
- 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 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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