MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. SEVEN XD INT. HEX. IMPLANT D4.2 L16M , SP; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	MF7-D16420
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 failure.

• Brand Name: SEVEN XD INT. HEX. IMPLANT D4.2 L16M , SP
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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: 23341529
• Report Number: 3004203816-2025-39982
• Device Sequence Number: 18094679
• Product Code: DZE
• UDI-Device Identifier: 07290113997851
• UDI-Public: 07290113997851
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K180282
• 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): 10/20/2025

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: MF7-D16420
• Device Lot Number: W24015500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Distributor Facility Aware Date: 10/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female