MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH 3 - STEP DRILL EV Ø 2.5/3.1, 6-17 MM; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	25168
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	04/16/2026
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.The product is not available for investigation.Trend is tracked and monitored.
Event or Problem Description
It was reported that the patient moved during the procedure, causing the drill to deviate outside the facial bone, which made it impossible to proceed with implant placement at the site.Bone graft material and a collagen plug were placed.The site will be re-evaluated with a ct scan in 3¿4 months.

• Brand Name: 3 - STEP DRILL EV Ø 2.5/3.1, 6-17 MM
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 25154128
• Report Number: 3013111692-2026-15583
• Device Sequence Number: 9351987
• Product Code: NDP
• UDI-Device Identifier: 07392532146510
• UDI-Public: 07392532146510
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 05/12/2026

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: 25168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/24/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/12/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown