MAUDE Adverse Event Report: MIS Implants Technologies Ltd. Lance internal hex. implant dia. 3.75 L 11.50mm; implant, endosseous, root-form

Catalog Number	MF5-11375
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

• Brand Name: Lance internal hex. implant dia. 3.75 L 11.50mm
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): MIS Implants Technologies Ltd.; p.o. box 7; 2015600 bar lev industrial par; IS
• Manufacturer (Section G): MIS Implants Technologies Ltd.; p.o. box 7; 2015600 bar lev industrial par; IS
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50810092
• Report Number: 3004203816-2026-26405
• Device Sequence Number: 21480165
• Product Code: DZE
• UDI-Device Identifier: 07290113995673
• UDI-Public: 07290113995673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192149
• 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
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MF5-11375
• Device Lot Number: W24015919
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/17/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown