MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ABUTMENT SCREW 3.0; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	24189
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product return is requested and product 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 implant fracture.The implant was for the 12 abutment and the crown edge was slightly insufficient.When the force reached 15 n, the central screw in the 12 restoration abutment broke.
Additional Manufacturer Narrative
Adding additional information: fracture of screw caused implant removal.This is a follow up report for this additional information.Device received for this event is being corrected from tidesign 3.0 - ø4.0 - 15° catalog # 24790 to abutment screw 3.0 catalog # 24189.This is a follow up report for this corrected information.Correcting udi # from (b)(4) to (b)(4).This is a follow up report for this corrected information.

• Brand Name: ABUTMENT SCREW 3.0
• 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: 23189102
• Report Number: 3013111692-2025-28672
• Device Sequence Number: 9063136
• Product Code: NHA
• UDI-Device Identifier: 07392532072772
• UDI-Public: 07392532072772
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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,Followup
• Report Date (Section B): 11/03/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2021
• Device Catalogue Number: 24189
• Device Lot Number: 471652
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/21/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANT 24983
• Patient Sex: Unknown