Touareg CloseFit™ RP Dental Implant 3.5D 11.5L ISPX1135Recalls & reported problems
Adin Dental Implant Systems Ltd · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07290105152251), received between Feb 7, 2025 and Sep 6, 2026 — classified as 15 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
- Patient Device Interaction Problem7
- Failure to Osseointegrate1
Patient problems
- Inadequate Osseointegration9
- Bacterial Infection6
- Failure of Implant4
- Pain4
- Sinus Perforation1
- Unspecified Infection1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2026Failure to Osseointegrate; Osseointegration Problem
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50637918 ↗InjuryApr 28, 2026Osseointegration Problem
MOBILITY 10 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25020464 ↗InjurySep 12, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 2 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23038888 ↗InjuryJul 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
INFECTION AND SINUS PENETRATION ONE DAY AFTER IMPLANTATION. PATIENT WITH HYPERTENSION.
Patient problems: Bacterial Infection; Sinus Perforation
MAUDE report 22576770 ↗InjuryJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
INFECTION, MOBILITY AND PAIN A MONTH AFTER IMPLANTATION PATIENT WITH CHEMOTHERAPY, HYPERTENSION AND ALCOHOLISM.
Patient problems: Bacterial Infection; Inadequate Osseointegration; Pain
MAUDE report 22485174 ↗InjuryJul 11, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 3 MONTHS AFTER IMPLANTATION. PATIENT WITH HYPERTENSION.
Patient problems: Inadequate Osseointegration
MAUDE report 22485172 ↗InjuryJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
INFECTION 1 MONTH AFTER IMPLANTATION, PATIENT WITH DIABETES.
Patient problems: Bacterial Infection
MAUDE report 22485166 ↗InjuryJun 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22283085 ↗InjuryJun 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
INFECTION ONE DAY AFTER IMPLANTATION. DIABETIC PATIENT.
Patient problems: Bacterial Infection
MAUDE report 22195423 ↗InjuryJun 5, 2025Osseointegration Problem; Osseointegration Problem
DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 22151393 ↗InjuryMay 25, 2025Osseointegration Problem; Osseointegration Problem
DENTAL IMPLANT FAILURE
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 22082528 ↗InjuryMay 2, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 8 MONTHS AFTER IMPLANTANTION. IMPLANT NEVER RESTORED.
Patient problems: Inadequate Osseointegration
MAUDE report 21951984 ↗InjuryApr 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PAIN AND INFECTION 9 DAYS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Pain
MAUDE report 21539999 ↗InjuryFeb 7, 2025Osseointegration Problem; Osseointegration Problem
PAIN, MOBILITY AND INFECTION 2 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration; Pain
MAUDE report 21337306 ↗
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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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