MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD TOUAREG UNIFIT DENTAL IMPLANT 3.75D 10L

Model Number	ISPUF1038
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Dental implant failure.
Additional Manufacturer Narrative
The doctor reported that while trying to remove a stuck screw, the driver broke and the implant fell.No further patient complications were reported.Manufacturer's trend analysis show that implant failure is a low-rate adverse event, which is common for endosseus dental implants in clinical use.

• Brand Name: TOUAREG UNIFIT DENTAL IMPLANT 3.75D 10L
• Common Device Name: TOUAREG UNIFIT DENTAL IMPLANT 3.75D 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: 23275175
• Report Number: 3007518363-2025-04460
• Device Sequence Number: 4928061
• Product Code: DZE
• UDI-Device Identifier: 07290109303048
• UDI-Public: 07290109303048
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K223714
• 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): 10/12/2025

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: ISPUF1038
• Device Catalogue Number: ISPUF1038
• Device Lot Number: 7881801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 10/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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