MAUDE Adverse Event Report: MIS Implants Technologies Ltd. C1 XD coni. con. implant D3.30 L13mm , NP; implant, endosseous, root-form

Lot Number	W24016772
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced dental implant loss.The patient underwent surgery for the placement of five implants at sites 1.6, 1.5, 1.4, 1.1, and 2.1.On the day of the phase ii surgery, lack of osseointegration was observed at implant site 1.1.
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.

• Brand Name: C1 XD coni. con. implant D3.30 L13mm , NP
• 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: 50677065
• Report Number: 3004203816-2026-25380
• Device Sequence Number: 5166643
• Product Code: DZE
• UDI-Device Identifier: 07290113996175
• UDI-Public: 07290113996175
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K172505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: W24016772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/08/2026
• 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: 66 YR
• Patient Sex: Male