MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. TI BASE ANTI ROTATION, GINGIVA H.1.5MM, CONI. CON., SP; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	CS-TB015
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A fractured abutment had led to the implant being no longer restorable and needed to be removed.Dentsply sirona implants is not the legal manufacturer of the fractured abutment that caused the event.
Event or Problem Description
It was reported that a patient experienced a ti-base fracture.

• Brand Name: TI BASE ANTI ROTATION, GINGIVA H.1.5MM, CONI. CON., SP
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer (Section G): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24735075
• Report Number: 3004203816-2026-08783
• Device Sequence Number: 16018685
• Product Code: NHA
• UDI-Device Identifier: 07290109003818
• UDI-Public: 07290109003818
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K191152
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: CS-TB015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Distributor Facility Aware Date: 03/11/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown