MAUDE Adverse Event Report: ADIN DENTAL IMPLANTS LTD. ADIN DENTAL IMPLANTS.; ISPX0849

Catalog Number	ISPX0849
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Infection 3 days after implantation, patient with hypertension.

• Brand Name: ADIN DENTAL IMPLANTS.
• Common Device Name: ISPX0849
• Manufacturer (Section D): ADIN DENTAL IMPLANTS LTD.; industrial zone alon tavor; pob 1128; afula, isr, 18111 01; IS 1811101
• MDR Report Key: 22135806
• Report Number: 3013143972-2025-00326
• Device Sequence Number: 8371383
• Product Code: DZE
• UDI-Device Identifier: 07290105152169
• UDI-Public: 7290105152169
• Combination Product (Y/N): N
• 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: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/03/2025
• Report Date (Section F): 06/03/2025

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 Catalogue Number: ISPX0849
• Device Lot Number: 7793804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/03/2025