MAUDE Adverse Event Report: Dentsply Implants Manufacturing GmbH TiDesign 3.5/4.0 - Ø 6.5, 3mm; abutment, implant, dental, endosseous

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced an astra tidesign abutment fracture, with the fractured hexagonal portion remaining retained inside the astra implant at tooth position 36.

• Brand Name: TiDesign 3.5/4.0 - Ø 6.5, 3mm
• Common Device Name: abutment, implant, dental, endosseous
• Manufacturer (Section D): Dentsply Implants Manufacturing GmbH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: mr. dan eagar; suite 60w; york, PA 17401
• MDR Report Key: 50858422
• Report Number: 3013111692-2026-41994
• Device Sequence Number: 10026025
• Product Code: NHA
• UDI-Device Identifier: 07392532067563
• UDI-Public: 07392532067563
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown