MAUDE Adverse Event Report: MIS Implants Technologies Ltd. SEVEN internal hex. implant dia. 3.75 L 10mm; implant, endosseous, root-form

Lot Number	W24005026
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction

• Brand Name: SEVEN internal hex. implant dia. 3.75 L 10mm
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): MIS Implants Technologies Ltd.; p.o. box 7; bar lev industrial par 20156 00; IS 2015600
• Manufacturer Contact: mr. dan eagar; suite 60w; york, PA 17401
• MDR Report Key: 50937411
• Report Number: 3004203816-2026-27797
• Device Sequence Number: 9498920
• Product Code: DZE
• UDI-Device Identifier: 07290108999198
• UDI-Public: 07290108999198
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Lot Number: W24005026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown