MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION® PRO TCF; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number	770445
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
1 of 1 devices were returned for evaluation.Evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication.The device did not heat up during evaluation.The device was repaired and returned to the customer.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.
Event or Problem Description
This report summarizes 1 malfunction event where a midwest tradition® pro tcf handpiece overheated.1 event resulted in no injury.
Additional Manufacturer Narrative
This follow up report provides the requested update to add vmsr to the exemption/variance number field.

• Brand Name: MIDWEST TRADITION® PRO TCF
• 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: 23389455
• Report Number: 9614977-2025-00025
• Device Sequence Number: 13256596
• Product Code: EFB
• UDI-Device Identifier: E2767704450
• UDI-Public: E2767704450
• Combination Product (Y/N): N
• PMA/510(K) Number: K131319
• Exemption Number: VMSR
• Number of Events Summarized: 1
• 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: 770445
• 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: 10/27/2025
• Supplement Report FDA Received Date: 02/02/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown