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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

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: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 3 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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

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.