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

Catalog Number	MG-STN1
Medical Device Problem Codes	Positioning Failure (1158); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since a serious injury resulted, this event is reportable per 21 cfr part 803.Additional information was requested, and case will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.
Event or Problem Description
It was reported that despite planning implant placement with mguide, bone was missing.There was no primary-stability, and the implant was replaced by a shorter implant.

• 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: 23942654
• Report Number: 3007362683-2026-00001
• Device Sequence Number: 10683603
• Product Code: NDP
• UDI-Device Identifier: 07392532253140
• UDI-Public: 07392532253140
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 01/02/2026
• 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