MAUDE Adverse Event Report: Adin Dental Implant Systems LTD Touareg CloseFit NP Dental Implant 3.0D 13L

Model Number	ISPNP1330
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Dental implant failure.
Additional Manufacturer Narrative
The doctor reported two dental implant failures in which the fixture mount could not be removed from the implant during surgery: ispnp1330 lot no.7864310, and ispnp1130 lot no.7951502.As a result, the implants were removed.No additional patient complications were reported.The manufacturer's investigation and trend analysis indicate that this is a low-frequency adverse event and a known complication associated with the clinical use of endosseous dental implants.No evidence indicating a product-related or manufacturing-related issue was identified.

• Brand Name: Touareg CloseFit NP Dental Implant 3.0D 13L
• Common Device Name: Touareg CloseFit NP Dental Implant 3.0D 13L
• 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: 50687533
• Report Number: 3007518363-2026-05241
• Device Sequence Number: 10349374
• Product Code: DZE
• UDI-Device Identifier: 07290105151698
• UDI-Public: 07290105151698
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K140293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/09/2026

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: ISPNP1330
• Device Catalogue Number: ISPNP1330
• Device Lot Number: 7864310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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 Age: 52 YR
• Patient Sex: Male