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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

All Accessories, implant, dental, endosseous devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.