MAUDE Adverse Event Report: MIS Implants Technologies Ltd. Ti Base anti rotation, gingiva h.3mm, coni. con., SP; Abutment, Implant, Dental, Endosseous

Catalog Number	CS-TB030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2026
Type of Reportable Event	Malfunction

• Brand Name: Ti Base anti rotation, gingiva h.3mm, coni. con., SP
• Common Device Name: Abutment, Implant, Dental, Endosseous
• Manufacturer (Section D): MIS Implants Technologies Ltd.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer (Section G): MIS Implants Technologies Ltd.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50053689
• Report Number: 3004203816-2026-18627
• Device Sequence Number: 9481418
• Product Code: NHA
• UDI-Device Identifier: 07290109003825
• UDI-Public: 07290109003825
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K191152
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-TB030
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/28/2026
• 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
• Patient Sex: Unknown