MAUDE Adverse Event Report: NORIS MEDICAL LTD MBI IMPLANT; MBI DENTAL IMPLANT

Model Number	NM-V2910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Was returned wrong device for analysis, it does not match the sticker and lot.Complaint history and product history records were reviewed for lot #0031103, and documentation indicated the product met release criteria.The root cause has not been identified.Should the device be returned, an investigation will be completed, and a supplemental report will be submitted after the investigation.
Event or Problem Description
The implant was removed during implant placement day on (b)(6) 2025.Observed during the event: implant boll top broke.The malfunction did not cause or contribute to a death or serious injury.No patient operative or post-operative complications reported.Was returned wrong device for analysis, it does not match the sticker and lot.

• Brand Name: MBI IMPLANT
• Common Device Name: MBI DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• Manufacturer (Section G): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• Manufacturer Contact: anna dvinska ; hataasia 8; nesher, 36888-08 ; IS 3688808
• MDR Report Key: 24542559
• Report Number: 3011390931-2026-00077
• Device Sequence Number: 14868310
• Product Code: DZE
• UDI-Device Identifier: 07290108814514
• UDI-Public: 07290108814514
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/08/2026

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 Model Number: NM-V2910
• Device Catalogue Number: NM-V2910
• Device Lot Number: 0031103
• 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: 02/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian