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Midwest Stylus® Plus 792400Recalls & reported problems

SIRONA Dental Systems GmbH · Midwest Stylus® Plus SPM · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 E2767924000), received between Jan 22, 2024 and Oct 27, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 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: 1 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: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 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 Device4

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Burn(s)1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 27, 2025Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST STYLUS® PLUS SPM HANDPIECE OVERHEATED. 1 EVENT RESULTED IN NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23389456 ↗
  • MalfunctionApr 22, 2025Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST STYLUS® PLUS SPM HANDPIECE OVERHEATED. 1 EVENT RESULTED IN DOCTOR BEING SLIGHTLY BURNED WITH NO INTERVENTION.

    Patient problems: Burn(s)

    MAUDE report 21880820 ↗
  • MalfunctionJan 24, 2025Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS WHERE A MIDWEST STYLUS® PLUS SPM HANDPIECE OVERHEATED. 2 EVENTS RESULTED IN NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21232203 ↗
  • MalfunctionJan 22, 2024Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST STYLUS PLUS HANDPIECE OVERHEATED. THE 1 EVENT RESULTED IN NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18556622 ↗

Other Handpiece, Air-Powered, Dental devices

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Sources and updates

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