MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH FORZA PRO 1:5 FG; CONTRA-ANGLE HAND PIECE

Catalog Number	5029811U0 (BRASSELER)
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At the beginning of a crown and bridge prep on tooth #29 the patient was burned inside the mouth.They were given local anesthetic, pain medicine and antibiotics.
Additional Manufacturer Narrative
The investigation revealed that there is no defect and that the handpiece is in good condition.The overheating could not be reproduced during the analysis.
Event or Problem Description
At the beginning of a crown and bridge prep on tooth #29 the patient was burned inside the mouth.They were given local anesthetic, pain medicine and antibiotics.

• Brand Name: FORZA PRO 1:5 FG
• Common Device Name: CONTRA-ANGLE HAND PIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser strasse 53; buermoos, 5111 ; AS 5111
• Manufacturer Contact: gerhard weidler ; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• MDR Report Key: 23334283
• Report Number: 3003755849-2025-00006
• Device Sequence Number: 9937518
• Product Code: EFB
• UDI-Device Identifier: 00887919941972
• UDI-Public: 00887919941972
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5029811U0 (BRASSELER)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Male