Touareg™-S Dental Implant 3.5D 11.5L ISPS1135Recalls & reported problems

Adin Dental Implant Systems Ltd · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This ADIN Touareg-S dental implant drew 41 adverse event reports, with 41 injuries and no deaths. Most describe infections, mobility, or loss of osseointegration after implantation. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 44
Deaths reported: 0
Injuries reported: 44
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07290105151858), received between Jul 7, 2024 and Sep 10, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loss of Osseointegration15
Osseointegration Problem15
Patient Device Interaction Problem13
Fracture2
Failure to Osseointegrate1

Patient problems

Inadequate Osseointegration30
Bacterial Infection18
Failure of Implant5
Pain3
Granuloma1
Osteolysis1

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

InjurySep 10, 2026Loss of Osseointegration; Osseointegration Problem
Dental implant failure.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50712570 ↗
InjurySep 10, 2026Osseointegration Problem
Dental implant failure.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50712567 ↗
InjurySep 6, 2026Failure to Osseointegrate; Osseointegration Problem
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50637908 ↗
InjuryMay 22, 2026Patient Device Interaction Problem
INFECTION 6 WEEKS AFTER IMPLANTATION.
Patient problems: Bacterial Infection
MAUDE report 25256974 ↗
InjuryMay 22, 2026Osseointegration Problem
INFECTION 3 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection
MAUDE report 25256973 ↗
InjuryMay 1, 2026Loss of Osseointegration
INFECTION AND MOBILITY 3 YEARS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 25058013 ↗
InjuryMay 1, 2026Loss of Osseointegration
INFECTION AND BONE LOSS 3 YEARS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 25058010 ↗
InjuryMay 1, 2026Osseointegration Problem
MOBILITY 2 1/2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25057996 ↗
InjuryMay 1, 2026Patient Device Interaction Problem
MOBILITY 1 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25057993 ↗
InjuryMar 23, 2026Patient Device Interaction Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24664759 ↗
InjuryFeb 16, 2026Patient Device Interaction Problem
MOBILITY 4 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24345315 ↗
InjuryFeb 4, 2026Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24260581 ↗
InjuryFeb 3, 2026Patient Device Interaction Problem
INFECTION AND MOBILITY 1 YEAR AND 2 MONTHS AFTER IMPLANTATION. DIABETIC AND SMOKER.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 24246807 ↗
InjuryFeb 3, 2026Patient Device Interaction Problem
GRANULOMA AND INFECTION 1 MONTH AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Granuloma; Inadequate Osseointegration
MAUDE report 24246806 ↗
InjuryJan 12, 2026Patient Device Interaction Problem
INFECTION TWO WEEKS AFTER IMPLANTATION.
Patient problems: Bacterial Infection
MAUDE report 24036994 ↗
InjuryJan 12, 2026Osseointegration Problem
INFECTION AND MOBILITY 2 WEEKS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 24036614 ↗
InjuryJan 12, 2026Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24036575 ↗
InjuryJan 12, 2026Patient Device Interaction Problem
INFECTION 3 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection
MAUDE report 24036544 ↗
InjuryJan 12, 2026Osseointegration Problem
MOBILITY 6 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24036500 ↗
InjuryJan 12, 2026Osseointegration Problem
MOBILITY 6 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24036310 ↗
InjuryNov 25, 2025Osseointegration Problem; Osseointegration Problem
INFECTION 3 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection
MAUDE report 23650068 ↗
InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
MOBILITY 3 YEARS AND 4 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23487416 ↗
InjuryAug 20, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 15 DAYS AFTER IMFLAMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22854373 ↗
InjuryAug 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MOBILITY 2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22820329 ↗
InjuryAug 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PAIN AND INFECTION 12 DAYS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Pain
MAUDE report 22705716 ↗

Device details

UDI-DI	`07290105151858`
Brand	Touareg™-S Dental Implant 3.5D 11.5L
Model	ISPS1135
Company	Adin Dental Implant Systems Ltd
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K081751
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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All Implant, Endosseous, Root-Form devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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