MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRI STANDARD ABUTMENT SCREW; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	45-4305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient experienced a dental implant fracture.
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.The product is not available for investigation.In case any new or additional information a follow-up report will be sent.Trend is tracked and monitored.

• Brand Name: FRI STANDARD ABUTMENT SCREW
• 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: 24948221
• Report Number: 3013111692-2026-13667
• Device Sequence Number: 20149787
• Product Code: DZE
• UDI-Device Identifier: 07392532228834
• UDI-Public: 07392532228834
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K945847
• 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): 04/21/2026

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: 45-4305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NOT PROVIDED
• Patient Sex: Unknown