Touareg™-S Dental Implant 4.2D 10L ISPS1042Recalls & 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 Dental Touareg-S root-form dental implant is used as a tooth replacement anchor in the jawbone. The 47 reports mostly describe the implant not fusing properly with the bone, becoming loose, and ongoing pain or infection. All 47 reports involved injuries, with no deaths. There are 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: 50
Deaths reported: 0
Injuries reported: 50
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 07290105151827), received between Oct 9, 2024 and Sep 10, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (28 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 Problem28
Patient Device Interaction Problem17
Loss of Osseointegration4
Fracture1

Patient problems

Inadequate Osseointegration38
Bacterial Infection11
Failure of Implant7
Pain6
Unspecified Infection2

Recent adverse event reports

The 25 most recent of 50 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 50712572 ↗
InjurySep 10, 2026Osseointegration Problem
Dental implant failure.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50712568 ↗
InjurySep 9, 2026Osseointegration Problem
Dental implant failure.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50686209 ↗
InjurySep 9, 2026Osseointegration Problem
Dental implant failure.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50686207 ↗
InjuryJul 10, 2026Osseointegration Problem
PAIN AND INFECTION 7 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Pain
MAUDE report 25786734 ↗
InjuryJul 7, 2026Osseointegration Problem
MOBILITY 6 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25738774 ↗
InjuryJul 7, 2026Loss of Osseointegration
BONE LOSS 5 YEARS AND 10 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25734809 ↗
InjuryJun 26, 2026Osseointegration Problem
MOBILITY 2 MONTS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25641339 ↗
InjuryJun 22, 2026Osseointegration Problem
MOBILITY 7 MONTHS AFTER IMPLANTATION. PATIENT WITH DIABETES AND HYPERTENSION.
Patient problems: Inadequate Osseointegration
MAUDE report 25586197 ↗
InjuryMay 28, 2026Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION. PATIENT WITH DIABETES AND HYPERTENSION.
Patient problems: Inadequate Osseointegration
MAUDE report 25318407 ↗
InjuryMay 26, 2026Osseointegration Problem
PAIN, INFECTION AND BONE LOSS 7 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration; Pain
MAUDE report 25278514 ↗
InjuryMay 12, 2026Patient Device Interaction Problem
INFECTION 3 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection
MAUDE report 25149253 ↗
InjuryMay 1, 2026Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION. DIABETIC PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 25058012 ↗
InjuryMay 1, 2026Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25057992 ↗
InjuryApr 28, 2026Osseointegration Problem
BONE LOSS 1 YEAR AND 2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25020754 ↗
InjuryMar 23, 2026Patient Device Interaction Problem
MOBILITY 1 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24664744 ↗
InjuryMar 23, 2026Patient Device Interaction Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24664741 ↗
InjuryMar 23, 2026Patient Device Interaction Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24664739 ↗
InjuryMar 23, 2026Osseointegration Problem
MOBILITY AND INFECTION 7 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 24664731 ↗
InjuryJan 26, 2026Patient Device Interaction Problem
MOBILITY ONE MONTH AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24181804 ↗
InjuryNov 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23534163 ↗
InjuryNov 12, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY ONE MONTH AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23534152 ↗
InjuryNov 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MOBILITY 2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23534149 ↗
InjuryNov 11, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23525603 ↗
InjuryNov 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MOBILITY 2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23525602 ↗

Device details

UDI-DI	`07290105151827`
Brand	Touareg™-S Dental Implant 4.2D 10L
Model	ISPS1042
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.

Other Implant, Endosseous, Root-Form devices

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STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
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Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
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23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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22,267 reports

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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