MAUDE Adverse Event Report: ADIN DENTAL IMPLANTS LTD. ADIN DENTAL IMPLANTS; ISPX1043

Catalog Number	ISPX1043
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Sinus Perforation (2277); Inadequate Osseointegration (2646)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pain, bone loss, sinus penetration, infection 3 months after implantation.

• Brand Name: ADIN DENTAL IMPLANTS
• Common Device Name: ISPX1043
• Manufacturer (Section D): ADIN DENTAL IMPLANTS LTD.; industrial zone alon tavor; pob 1128; afula, isr, 18111 01; IS 1811101
• MDR Report Key: 22485158
• Report Number: 3013143972-2025-00397
• Device Sequence Number: 8041010
• Product Code: DZE
• UDI-Device Identifier: 07290105152213
• UDI-Public: 7290105152213
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/11/2025
• Report Date (Section F): 07/11/2025

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: ISPX1043
• Device Lot Number: 7751905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/07/2025
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• 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: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/11/2025