MAUDE Adverse Event Report: Adin Dental Implant Systems LTD Touareg¿-S Dental Implant 3.5D 11.5L

Model Number	ISPS1135
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Dental implant failure.
Additional Manufacturer Narrative
Manufacturers 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¿-S Dental Implant 3.5D 11.5L
• Common Device Name: Dental implant
• Manufacturer (Section D): Adin Dental Implant Systems LTD; industrial zone alon tavor; pob 1128; afula
• Manufacturer (Section G): Adin Dental Implant Systems LTD; industrial zone alon tavor; pob 1128; afula 18110 1; IS 181101
• Manufacturer Contact: ilana lutvak ; industrial zone alon tavor; pob 1128; afula 18110-1 ; IS 181101
• MDR Report Key: 50712567
• Report Number: 3007518363-2026-05246
• Device Sequence Number: 13408197
• Product Code: DZE
• UDI-Device Identifier: 07290105151858
• UDI-Public: 07290105151858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ISPS1135
• Device Catalogue Number: ISPS1135
• Device Lot Number: 7993119
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female