MAUDE Adverse Event Report: MIS Implants Technologies Ltd. C1 coni. con. implant D4.20 L8mm, SP; implant, endosseous, root-form

Catalog Number	C1-08420
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

• Brand Name: C1 coni. con. implant D4.20 L8mm, SP
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): MIS Implants Technologies Ltd.; p.o. box 7; 2015600 bar lev industrial; IS
• Manufacturer (Section G): MIS Implants Technologies Ltd.; p.o. box 7; 2015600 bar lev industrial par; IS
• Manufacturer Contact: dan eager ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 1(717)845-7511
• MDR Report Key: 50937679
• Report Number: 3004203816-2026-27802
• Device Sequence Number: 15886316
• Product Code: DZE
• UDI-Device Identifier: 07290108992021
• UDI-Public: 07290108992021
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K112162
• 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,Distributor
• Initial Reporter Occupation: Dentist
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: C1-08420
• Device Lot Number: W24004900
• Was Device Available for Evaluation?: No
• 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: 09/29/2026
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown