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Midwest Tradition® 790344Recalls & reported problems

SIRONA Dental Systems GmbH · Midwest Tradition® TB · Class 1

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI E2767903440), received between Apr 25, 2024 and Apr 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (5 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: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 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: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device5

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • Burn(s)1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 23, 2026Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST HIGHSPEED TRADITION® HANDPIECE OVERHEATED. 1 EVENT RESULTED IN NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24964086 ↗
  • MalfunctionJan 20, 2026Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE MIDWEST TRADITION® TB HANDPIECES OVERHEATED. 1 EVENT RESULTED IN NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24115906 ↗
  • MalfunctionApr 22, 2025Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST TRADITION® TB HANDPIECE OVERHEATED. 1 EVENT RESULTED IN NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21880822 ↗
  • MalfunctionOct 23, 2024Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS WHERE A MIDWEST TRADITION® TB HANDPIECE OVERHEATED. 1 EVENT RESULTED IN THE PATIENT BEING SLIGHTLY BURNED WITH NO INTERVENTION.

    Patient problems: Burn(s)

    MAUDE report 20514193 ↗
  • MalfunctionApr 25, 2024Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. WHERE A MIDWEST TRADITION HANDPIECE OVERHEATED. 2 EVENTS RESULTED IN NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19181039 ↗

Other Handpiece, Air-Powered, Dental devices

All Handpiece, Air-Powered, Dental devices →

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