MAUDE Adverse Event Report: Dentsply Implants Manufacturing GmbH OsseoSpeed TX 4.5 - 9 mm; implant, endosseous, root-form

Catalog Number	24951
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a fracture of a dental implant with infection.Concomitant product- healing abutment 6.5 x 4mm , 24586, eh 9-2-26.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.

• Brand Name: OsseoSpeed TX 4.5 - 9 mm
• 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 63457 ; GM 63457
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50913936
• Report Number: 3013111692-2026-42475
• Device Sequence Number: 20271942
• Product Code: DZE
• UDI-Device Identifier: 07392532108235
• UDI-Public: 07392532108235
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K111287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 24951
• Device Lot Number: 123913
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown