MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK ABUT SNAP ATT C/A/4,5; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	17-2334
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental abutment fracture that resulted in loss of the dental implant as well.This report is for the dental abutment fracture.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.The associated report for the dental implant loss was submitted under mfr report # 3013111692-2025-33381.
Additional Manufacturer Narrative
Additional information received that the abutment is not fractured.This is a follow up report for this additional information.Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 1260, investigation findings code - 3252.The physical investigation of the returned items revealed that no fracture had occurred.The correct codes for this complaint are: medical device problem code - 2547, investigation findings code - 3253, this is a follow up report to correct these/this code(s).

• Brand Name: ANK ABUT SNAP ATT C/A/4,5
• 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: 23616127
• Report Number: 3013111692-2025-33382
• Device Sequence Number: 15721477
• Product Code: DZE
• UDI-Device Identifier: 07392532215452
• UDI-Public: 07392532215452
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K041509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/27/2026

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: 17-2334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/17/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown