MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRI SCREW FOR ESTHETICBASE D3,4-5,5; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	46-4305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dentsply sirona became aware of a malfunction that occurred while using the.This report is for the dental abutment device.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation, a follow-up report will be sent.Trend is tracked and monitored.
Event or Problem Description
It was reported that a patient experienced a fracture of abutment.

• Brand Name: FRI SCREW FOR ESTHETICBASE D3,4-5,5
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23857764
• Report Number: 3013111692-2025-35839
• Device Sequence Number: 12044339
• Product Code: DZE
• UDI-Device Identifier: 07392532231612
• UDI-Public: 07392532231612
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: 46-4305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT PROVIDED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown