MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. TI BASE H. 4MM WITH HEX., INT. HEX., WP; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	MW-TB001
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.

• Brand Name: TI BASE H. 4MM WITH HEX., INT. HEX., WP
• 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: 21775456
• Report Number: 3004203816-2025-18985
• Device Sequence Number: 8220504
• Product Code: NHA
• UDI-Device Identifier: 07290109001821
• UDI-Public: 07290109001821
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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 Catalogue Number: MW-TB001
• Device Lot Number: W24001451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Distributor Facility Aware Date: 03/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown