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

Model Number	NM-V3311
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Label of tuff implant was on package with mono implant.It was identified by the employee of noris medical inc - subsidiary of noris medical ltd ( importer - distributor) in the stock warehouse.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: MONO IMPLANT
• Common Device Name: MONO DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; 8 hataasia; nesher, 36888 08; IS 3688808
• Manufacturer Contact: simha sibony ; 8 hataasia; nesher, 36888-08 ; IS 3688808
• MDR Report Key: 17077773
• Report Number: 3011390931-2023-00001
• Device Sequence Number: 14015736
• Product Code: DZE
• UDI-Device Identifier: 07290108814606
• UDI-Public: 07290108814606
• Combination Product (Y/N): Y
• PMA/510(K) Number: K140440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

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
• Device Expiration Date: 12/10/2025
• Device Model Number: NM-V3311
• Device Catalogue Number: NM-V3311
• Device Lot Number: 7000487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 12/19/2024; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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 Sex: Unknown