Touareg™-S Dental Implant 3.5D 8L ISPS0835Recalls & reported problems

Adin Dental Implant Systems Ltd · Class 2 · Implant

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

Adverse event reports: 23
Deaths reported: 1
Injuries reported: 22
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07290105151759), received between Feb 4, 2025 and Sep 10, 2026 — classified as 1 death, 22 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (12 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

Osseointegration Problem12
Patient Device Interaction Problem6
Loss of Osseointegration5
Failure to Osseointegrate1

Patient problems

Inadequate Osseointegration20
Failure of Implant6
Bacterial Infection4
Pain2
Unspecified Infection2

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

InjurySep 10, 2026Osseointegration Problem
Dental implant failure.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50712569 ↗
InjurySep 10, 2026Osseointegration Problem
Dental implant failure.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50712566 ↗
InjurySep 6, 2026Failure to Osseointegrate; Osseointegration Problem
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50637910 ↗
InjuryMay 1, 2026Patient Device Interaction Problem
MOBILITY 2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25058002 ↗
InjuryMay 1, 2026Osseointegration Problem
MOBILITY 5 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25058000 ↗
DeathMay 1, 2026Loss of Osseointegration
MOBILITY 2 YEARS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25057999 ↗
InjuryApr 28, 2026Osseointegration Problem
PAIN, INFECTION AND BONEL LOSS 8 MONTHS AFTER IMPLANTATION PATIENT WITH CANCER.
Patient problems: Bacterial Infection; Inadequate Osseointegration; Pain
MAUDE report 25020790 ↗
InjuryFeb 4, 2026Patient Device Interaction Problem
INFECTION 2 MONTH AFTER IMPLANTATION.
Patient problems: Bacterial Infection
MAUDE report 24260536 ↗
InjuryFeb 2, 2026Patient Device Interaction Problem
MOBILITY 4 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24240359 ↗
InjuryFeb 2, 2026Patient Device Interaction Problem
PAIN AND MOBILITY ONE MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 24240358 ↗
InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
MOBILITY 4 YEARS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23487399 ↗
InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
MOBILITY 2 YEARS AFTER IMPLANTANTION.
Patient problems: Inadequate Osseointegration
MAUDE report 23487395 ↗
InjuryNov 6, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 10 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23487388 ↗
InjuryOct 15, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23284844 ↗
InjuryOct 15, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 3 MONTH AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23284825 ↗
InjuryJun 19, 2025Osseointegration Problem; Osseointegration Problem
DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 22291564 ↗
InjuryJun 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22289033 ↗
InjuryJun 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22289032 ↗
InjuryMay 21, 2025Osseointegration Problem; Osseointegration Problem
INFECTION A MONTH AFTER IMPLANTATION, PATIENT IS A FORMER SMOKER AND HAS HYPERTENSION.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 22062592 ↗
InjuryMay 21, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 7 MONTHS AFTER IMPLANTATION, PATIENT WITH ULCERS AND COLITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 22062591 ↗
InjuryMay 21, 2025Osseointegration Problem; Osseointegration Problem
INFECTION ONE MONTH AFTER IMPLANTATION, PATIENT WITH HYPERTENSION AND FORMER SMOKER.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 22062590 ↗
InjuryFeb 4, 2025Loss of Osseointegration; Loss of Osseointegration
MOBILITY 8 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21305165 ↗
InjuryFeb 4, 2025Loss of Osseointegration; Loss of Osseointegration
MOBILITY 2 YEARS AFTER IMPLANTANTION.
Patient problems: Inadequate Osseointegration
MAUDE report 21305163 ↗

Device details

UDI-DI	`07290105151759`
Brand	Touareg™-S Dental Implant 3.5D 8L
Model	ISPS0835
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	Apr 19, 2021

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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