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

Lot Number	W19007172
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury

• 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 park 20156 00; IS 2015600
• Manufacturer Contact: mr. dan eagar; suite 60w; york, PA 17401
• MDR Report Key: 50722036
• Report Number: 3004203816-2026-25590
• Device Sequence Number: 15565936
• Product Code: DZE
• UDI-Device Identifier: 07290108999198
• UDI-Public: 07290108999198
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K180282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: No
• Device Lot Number: W19007172
• 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: 08/11/2026
• Initial Report FDA Received Date: 09/10/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female