MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. MGUIDE CASE,4 SITES; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	MG-STN4
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.This report relates to the guide.The event is currently under investigation to determine the root cause and any potential relationship to the device.All available information is being reviewed and additional analysis will be conducted as necessary.A follow-up medical device report will be submitted upon completion of the investigation or as soon as further relevant information becomes available.
Event or Problem Description
It was reported that four dental implants were placed in a patient's mouth using a mguide that was planned on msoft (non-dentsply sirona product) software and the implants are not in the same position as what was planned in the planning software.This report is for the mguide device.

• Brand Name: MGUIDE CASE,4 SITES
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg B-350 0; BE B-3500
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg B-350 0; BE B-3500
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24944833
• Report Number: 3007362683-2026-00004
• Device Sequence Number: 21339578
• Product Code: NDP
• UDI-Device Identifier: 07392532253171
• UDI-Public: 07392532253171
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/21/2026

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: MG-STN4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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