DS OmniTaper 68015130Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver TempBase long · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07392532266331), received between Jan 12, 2026 and May 25, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Mechanical Problem2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER FAILED TO HOLD THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270962 ↗InjuryApr 17, 2026Fracture
CUSTOMER REPORTED THE FRACTURE OF A CONTRA-ANGLE-LOCK OF AN IMPLANT DRIVER.THE SESSION WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912248 ↗MalfunctionApr 9, 2026Mechanical Problem
CUSTOMER REPORTED IMPLANT DRIVER HAS NO RETENTION, THE SESSION WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831994 ↗MalfunctionApr 2, 2026Fracture
CUSTOMER REPORTED A TOOL MALFUNCTION: THE TEMPBASE INSERTION TOOL BROKE DURING INSERTION. TOOL AND DAMAGED TEMPBASE RECEIVED; CALLED SALES REP: THE SESSION HAS ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772786 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE O-RING CAME OFF THE IMPLANT DRIVER. NO INJURIES RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032120 ↗
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.