MAUDE Adverse Event Report: Dentsply Implants Manufacturing GmbH OsseoSpeed EV 4.2 S - 9 mm; implant, endosseous, root-form

Catalog Number	25233
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

• Brand Name: OsseoSpeed EV 4.2 S - 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 Contact: dan edgar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50484969
• Report Number: 3013111692-2026-39559
• Device Sequence Number: 13305401
• Product Code: DZE
• UDI-Device Identifier: 07392532132599
• UDI-Public: 07392532132599
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 08/27/2026

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: 25233
• Device Lot Number: 544614
• 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: 08/18/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown