MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH Uni Abutment EV 4.8 - 2 mm; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	25567
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
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.Product return is requested and 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 a patient experienced a dental abutment breakage.The bridge on the multi-unit abutments will be remade.

• Brand Name: Uni Abutment EV 4.8 - 2 mm
• 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: 24340954
• Report Number: 3013111692-2026-06097
• Device Sequence Number: 4770798
• Product Code: DZE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120414
• 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,Followup
• Report Date (Section B): 09/07/2026

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: 25567
• Device Lot Number: 412600
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2026
• Supplement Report FDA Received Date: 09/07/2026
• 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: 3 CROWNS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown