Touareg™-S Dental Implant 3.5D 10L ISPS1035Recalls & reported problems
Adin Dental Implant Systems Ltd · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07290105151803), received between Oct 9, 2023 and May 21, 2026 — classified as 18 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (8 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
Most reported problems
Device problems
- Osseointegration Problem8
- Fracture4
- Patient Device Interaction Problem4
- Failure to Osseointegrate1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration14
- Failure of Implant5
- Bacterial Infection3
- Pain1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2026Patient Device Interaction Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25246299 ↗InjuryMay 1, 2026Loss of Osseointegration
MOBILITY 6 YEARS AND 5 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25057994 ↗InjuryApr 7, 2026Osseointegration Problem
MOBILITY 3 AND A HALF MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24807772 ↗InjuryFeb 16, 2026Patient Device Interaction Problem
MOBILITY 1 MONTH AFTER IMPLANTATION. PATIENT WITH ASTHMA.
Patient problems: Inadequate Osseointegration
MAUDE report 24345316 ↗InjuryJan 26, 2026Patient Device Interaction Problem
MOBILITY ONE MONTH AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24181807 ↗InjuryJan 14, 2026Fracture
InjuryDec 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MOBILITY AND INFECTION 1 MONTH AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 23830235 ↗InjuryNov 21, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY AND PAIN 6 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 23622469 ↗InjuryNov 21, 2025Osseointegration Problem; Osseointegration Problem
MOBILTY 3 MONTHS AFTER IMPLANTATION. PATIENT WITH DIABETES AND HYPERTENSION.
Patient problems: Inadequate Osseointegration
MAUDE report 23622456 ↗InjuryNov 17, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY A YEAR AND 6 MONTHS AFTER IMPLANTATION, PATIENT WITH HYPOTHYROIDISM.
Patient problems: Inadequate Osseointegration
MAUDE report 23569273 ↗InjuryJun 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 22291533 ↗InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 3 MONTH AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22161444 ↗InjuryMay 21, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22062597 ↗InjuryApr 29, 2025Fracture; Fracture
InjuryMar 12, 2025Fracture; Fracture
InjuryJan 17, 2025Osseointegration Problem; Osseointegration Problem
INFECTION AND MOBILITY 4 MONTHS AFTER IMPLANTATION, DIABETIC AND SMOKER PATIENT.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 21179802 ↗InjuryJan 17, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY AND INFECTION 4 MONTH AFTER IMPLANTATION. DIABETIC AND SMOKER PATIENT.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 21179800 ↗InjuryOct 9, 2023Fracture; Fracture
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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