MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD TOUAREG CLOSEFIT NP DENTAL IMPLANT 3.0D 10L

Model Number	ISPNP1030
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treating clinician reported that the implant had to be removed due to a fractured abutment screw, which could not be retrieved from the implant.The screw in question corresponds to adin abutment np3094 and had undergone laboratory processing (casting treatment) prior to clinical use.No additional patient complications were reported in relation to this incident.According to the manufacturer's trend analysis, implant failure resulting from a fractured and irretrievable abutment screw is considered a low-frequency adverse event.
Event or Problem Description
Dental implant failure due to fractured abutment screw.

• Brand Name: TOUAREG CLOSEFIT NP DENTAL IMPLANT 3.0D 10L
• Common Device Name: TOUAREG CLOSEFIT NP DENTAL IMPLANT 3.0D 10L
• Manufacturer (Section D): ADIN DENTAL IMPLANT SYSTEMS LTD; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer (Section G): ADIN DENTAL IMPLANT SYSTEMS LTD.; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer Contact: ilana lutvak ; industrial zone alon tavor; pob 1128; afula, ; IS
• MDR Report Key: 22070150
• Report Number: 3007518363-2025-00758
• Device Sequence Number: 8711230
• Product Code: DZE
• UDI-Device Identifier: 07290105151674
• UDI-Public: 07290105151674
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: D227888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: ISPNP1030
• Device Catalogue Number: ISPNP1030
• Device Lot Number: 7639526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown