MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. MGUIDE CASE, 1 SITE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	MG-STN1
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in the need for an additional surgery to complete implant placement, it is reportable per 21 cfr part 803.
Event or Problem Description
It was reported that while using a mguide, the sleeve already felt very tight when used with the drill.Due to friction and heat, the adhesive loosened and the sleeve came loose from the guide, making it unusable.This concerned an immediate extraction and implant placement.At this time, only the extraction has been performed.After the extraction, the doctor sutured the gum and is now allowing it time to heal.

• Brand Name: MGUIDE CASE, 1 SITE
• 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: 24579436
• Report Number: 3007362683-2026-00002
• Device Sequence Number: 13380633
• Product Code: NDP
• UDI-Device Identifier: 07392532253140
• UDI-Public: 07392532253140
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/12/2026

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-STN1
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: V3-11430: MIS V3 LENGTH 11.50MM AND DIAMETER 4.30
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown