N/A 68015262Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant Profile Driver (PM) long · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07392532254932), received between Jan 12, 2026 and Jun 29, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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
- Fracture6
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660986 ↗MalfunctionJun 16, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION; SESSION WAS SUCCESSFULLY ENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25520872 ↗MalfunctionJun 7, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE IMPLANT DOES NOT HOLD ON THE DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25421103 ↗MalfunctionMar 26, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A FAILURE TO HOLD THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698811 ↗MalfunctionMar 25, 2026Fracture
CUSTOMER REPORTED FOURFOLD BROKEN IMPLANT DRIVER TIPS. THE PROCEDURE HAS BEEN COMPLETED. DRIVERS USED ACCORDING TO PROCEDURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689291 ↗MalfunctionJan 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 24176295 ↗MalfunctionJan 12, 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 24040014 ↗
Other Accessories, implant, dental, endosseous devices
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- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.