MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MAXIMA ELITE 1:5 - T1 LINE; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number	6361849
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction event where a maxima elite 1:5 - t1 line handpiece overheated.1 event resulted in the patient being slightly burned with no intervention.
Additional Manufacturer Narrative
We are awaiting the return of one device.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.

• Brand Name: MAXIMA ELITE 1:5 - T1 LINE
• 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: 21880828
• Report Number: 9614977-2025-00010
• Device Sequence Number: 15613615
• Product Code: EFB
• UDI-Device Identifier: 00304040058015
• UDI-Public: 00304040058015
• Combination Product (Y/N): N
• PMA/510(K) Number: K972436
• 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
• Report Date (Section B): 04/15/2025

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: 6361849
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown