MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRI SCREW FOR ESTHETICBASE D3,4-5,5; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	46-4305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dentsply sirona became aware of a malfunction for same/similar devices that could have possibly caused or contributed to a serious injury.Products return is requested and they 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, during manual tightening of the crown screw on (b)(6) 2026, the screw fractured without the application of significant force.

• Brand Name: FRI SCREW FOR ESTHETICBASE D3,4-5,5
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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: 24690028
• Report Number: 3013111692-2026-09934
• Device Sequence Number: 18573519
• Product Code: DZE
• UDI-Device Identifier: 07392532231612
• UDI-Public: 07392532231612
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013438
• 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): 03/25/2026

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: 46-4305
• Device Lot Number: B260001001
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/25/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown