MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SIMPLANT GUIDE FILE DS DESIGN; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	37472
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/27/2025
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 investigation on the digital guide file shows that proposed implant planning positions # 8 and 9 with 3.6 mm implant was rejected by the customer.The customer changed the implant planning for positions # 8 and 9 to 3 mm implant.
Event or Problem Description
It was reported that a patient experienced issue with simplant guide file ds design.The customer changed to the implant planning to 3.0 mm implants on positions # 8 and 9 resulting in off-label use.The patient's implant failed as a result and was removed.

• Brand Name: SIMPLANT GUIDE FILE DS DESIGN
• 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: 21915437
• Report Number: 3007362683-2025-00005
• Device Sequence Number: 4059807
• Product Code: NDP
• UDI-Device Identifier: 07392532290459
• UDI-Public: 07392532290459
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K193405
• 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): 04/26/2025

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: 37472
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown