MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH 3/V-SLEEVE Ø3.1 ND; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	26023
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
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 long-time experience in the investigation of similar complaints.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.This report is related to mfr report # 3013111692-2025-26761.
Event or Problem Description
It was reported that a drill sleeve would only go so far, and it appears that something was broken inside.The drill could not be used, and the implant was placed with a non-guided approach.After assessing the implant position, the angulation was not accurate enough and the implant was removed.This report is for the drill sleeve.

• Brand Name: 3/V-SLEEVE Ø3.1 ND
• 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: 23038046
• Report Number: 3013111692-2025-26762
• Device Sequence Number: 18665950
• Product Code: NDP
• UDI-Device Identifier: 07392532168628
• UDI-Public: 07392532168628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 26023
• Device Lot Number: 527505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2024
• 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
• Patient Sex: Unknown