Touareg CloseFit™ RP Dental Implant 3.5D 8.0L ISPX0835Recalls & reported problems
Adin Dental Implant Systems Ltd · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290105152138), received between Feb 6, 2025 and Dec 25, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (4 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 Problem4
- Fracture1
- Loss of Osseointegration1
Patient problems
- Bacterial Infection3
- Inadequate Osseointegration3
- Failure of Implant1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 25, 2025Fracture; Fracture
InjurySep 12, 2025Osseointegration Problem; Osseointegration Problem
InjuryJul 11, 2025Loss of Osseointegration; Loss of Osseointegration
MOBILITY AND INFECTION A YEAR AFTER IMPLANTATION PATIENT WITH DIABETES AND SMOKER.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 22485156 ↗InjuryMay 2, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 9 MONTHS AFTER IMPLANTATION, IMPLANT WAS NEVER RESTORED.
Patient problems: Inadequate Osseointegration
MAUDE report 21952008 ↗InjuryFeb 7, 2025Osseointegration Problem; Osseointegration Problem
PAIN 2 MONTHS AFTER IMPLANTATION, SMOKER PATIENT.
Patient problems: Bacterial Infection
MAUDE report 21337303 ↗InjuryFeb 6, 2025Osseointegration Problem; Osseointegration Problem
PAIN AND MOBILITY A MONTH AFTER IMPLATATION. PATIENT WITH DIABETES AND HYPERTENSION.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 21326959 ↗
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- 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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