DS OmniTaper 68015129Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver TempBase short · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532266324), received between Jan 5, 2026 and May 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Device Handling Problem1
- Fracture1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329424 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component; Device Handling Problem
IT WAS REPORTED THAT THE O-RING SEPARATED FROM IMPLANT DRIVER CAUSING IMPLANT TO FALL DOWN, SESSION WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701324 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE O-RING HAS COME OFF THE IMPLANT DRIVE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032117 ↗MalfunctionJan 5, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER DOES NOT HOLD THE IMPLANT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960696 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.