MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH COVER SCREW EV (M); ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	68010005
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the cover screw could not be removed, resulting in a dental implant loss.
Additional Manufacturer Narrative
Dentsply sirona became aware of a serious injury that occurred while using the astra tech implant system.This report is for the dental cover screw device.The dental implant device report will be submitted separately.Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.

• Brand Name: COVER SCREW EV (M)
• Common Device Name: ABUTMENT, 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: 24288662
• Report Number: 3013111692-2026-05082
• Device Sequence Number: 9332358
• Product Code: NHA
• UDI-Device Identifier: 07392532256066
• UDI-Public: 07392532256066
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 68010005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/03/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/08/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALING ABUTM. 68013054.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown