MAUDE Adverse Event Report: DENTSPLY IH INC. 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	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our experience in the investigation of similar complaints.This report is for the digital (guide) planning device.The dental implant device report will be submitted separately.Product return is requested and product 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 implant placement was attempted.Lab assisted surgical guide was used at the time of implant placement.Punch, drill sequence, and implant was placed.The implant was too deep and angled.Implant was taken out and sutured up for area to heal so it could be attempted again at a later date.

• Brand Name: SIMPLANT GUIDE FILE DS DESIGN
• 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: 25499771
• Report Number: 1222802-2026-00080
• Device Sequence Number: 10520003
• Product Code: NDP
• UDI-Device Identifier: 07392532290459
• UDI-Public: 07392532290459
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/15/2026

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: 37472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown