MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH 20° UNI ABUTMENT 4.5/5.0-2MM; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	24400
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported loosening of three abutments.No injury resulted.
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 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.

• Brand Name: 20° UNI ABUTMENT 4.5/5.0-2MM
• 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: 23906041
• Report Number: 3013111692-2025-36413
• Device Sequence Number: 15958650
• Product Code: NHA
• UDI-Device Identifier: 07392532066238
• UDI-Public: 07392532066238
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/29/2025

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: 24400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/29/2025
• 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
• Patient Sex: Unknown