MAUDE Adverse Event Report: MIS Implants Technologies Ltd. Multi unit 17 deg. angulated abut., h. 1mm, int. hex., SP; Abutment, Implant, Dental, Endosseous

Catalog Number	MA-SA171
Medical Device Problem Code	Fracture (1260)
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 multi-unit abutment breakage.
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: Multi unit 17 deg. angulated abut., h. 1mm, int. hex., 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: 50037762
• Report Number: 3004203816-2026-18539
• Device Sequence Number: 10421129
• Product Code: NHA
• UDI-Device Identifier: 07290108998955
• UDI-Public: 07290108998955
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K180282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: MA-SA171
• Device Lot Number: W15009408
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Reported applied torque: 20 Ncm
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown