MAUDE Adverse Event Report: Dentsply Implants Manufacturing GmbH ANK C/X Impl A8/D3.5/L8; Endosseous dental implant

Catalog Number	31010405
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury

• Brand Name: ANK C/X Impl A8/D3.5/L8
• Common Device Name: Endosseous dental implant
• Manufacturer (Section D): Dentsply Implants Manufacturing GmbH; rodenbacher chaussee 4; hanau 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: 50796501
• Report Number: 3013111692-2026-41280
• Device Sequence Number: 13390790
• Product Code: DZE
• UDI-Device Identifier: 07392532205941
• UDI-Public: 07392532205941
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 31010405
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/16/2026
• 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