MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS® PLUS SPK; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number	792430
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
3 of 3 devices were returned for evaluation.Evaluation of three devices found excessive wear due to a lack of proper maintenance.A friction problem was identified from pressure on the cap.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.
Event or Problem Description
This report summarizes 3 malfunction events where midwest stylus® plus spk handpieces overheated.3 events resulted in no injury.
Additional Manufacturer Narrative
This is a follow up report adding vmsr to the exemption/variance number field.This was not included in the initial report.

• Brand Name: MIDWEST STYLUS® PLUS SPK
• Common Device Name: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 24115908
• Report Number: 9614977-2026-00002
• Device Sequence Number: 5941227
• Product Code: EFB
• UDI-Device Identifier: E2767924300
• UDI-Public: E2767924300
• Combination Product (Y/N): N
• PMA/510(K) Number: K131319
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 792430
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/02/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown