MAUDE Adverse Event Report: DENTSPLY IH INC. MGUIDE CASE, 1 SITE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	MG-STN1
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Failure of Implant (1924)
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.The dhr and the investigation of the digital file did not reveal anomalies.The investigation of returned material shows that the guide sleeve is definitely not seated fully due to interfering debris on the seating surface of the printed mguide.
Event or Problem Description
It was reported that an implant that was placed using a mguide is not in the same position as on the surgical plan.The implant is about 3.3mm toward the palatal and just barely in the palatal crestal bone.The doctor requested a second guide to be manufactured, and stated they would remove the first implant, add lingual bone, and place the second implant.At this time, there is no indication from the doctor regarding the second surgery.

• Brand Name: MGUIDE CASE, 1 SITE
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer (Section G): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21459301
• Report Number: 1222802-2025-00004
• Device Sequence Number: 15351278
• Product Code: NDP
• UDI-Device Identifier: 07392532253140
• UDI-Public: 07392532253140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/25/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2025
• 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