MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH HEALDESIGN EV 4.2 Ø5 - 4.5MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	25302
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dentsply sirona became aware of a malfunction that occurred while¿using the astra tech implant system.This report is for the dental abutment device.The dental implant device report was submitted under mfr report # xxxxxxx.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 dental implant fracture.
Additional Manufacturer Narrative
Adding udi # (b)(4).This is a follow up report for this additional information.Device received for this event is being corrected from unknown atis ev abutment catalog # unk atis ev abutment to healdesign ev 4.2 ø5, 4.5mmcatalog # 25302.This is a follow up report for this corrected information.

• Brand Name: HEALDESIGN EV 4.2 Ø5 - 4.5MM
• 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: 23439831
• Report Number: 3013111692-2025-31201
• Device Sequence Number: 18280944
• Product Code: DZE
• UDI-Device Identifier: 07392532144615
• UDI-Public: 07392532144615
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 12/17/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 25302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/17/2025
• 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
• Patient Sex: Unknown