Touareg CloseFit™ RP Dental Implant 3.5D 13L ISPX1335Recalls & reported problems
Adin Dental Implant Systems Ltd · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07290105152312), received between Feb 7, 2025 and May 13, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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
- Patient Device Interaction Problem6
- Osseointegration Problem3
Patient problems
- Inadequate Osseointegration7
- Bacterial Infection1
- Failure of Implant1
- Granuloma1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Osseointegration Problem
INFECTION AND MOBILITY 5 MONTHS AFTER IMPLANTATION.
Patient problems: Bacterial Infection; Inadequate Osseointegration
MAUDE report 25162765 ↗InjuryMay 12, 2026Osseointegration Problem
MOBILITY 5 MONTHS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25149258 ↗InjuryAug 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MOBILITY ONE DAY AFTER IMPLANTATION. SMOKER PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 22895589 ↗InjuryAug 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
BONE LOSS ONE DAY AFTER IMPLANTATION. PATIENT WITH HYPERTENSION.
Patient problems: Inadequate Osseointegration
MAUDE report 22854356 ↗InjuryJul 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
GRANULOMA AND MOBILITY ONE DAY AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22576777 ↗InjuryJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MOBILITY ONE MONTHS AFTER IMPLANTATION. SMOKER PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 22485189 ↗InjuryJun 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22283087 ↗InjuryJun 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
GRANULOMA 1 DAY AFTER IMPLANTATION. AS DOCTOR REPORTED.
Patient problems: Granuloma
MAUDE report 22195425 ↗InjuryFeb 7, 2025Osseointegration Problem; Osseointegration Problem
MOBILITY 2 WEEKS AFTER IMPLANTATION. PATIENT WITH DIABETES AND HYPERTENSION.
Patient problems: Inadequate Osseointegration
MAUDE report 21337319 ↗
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- 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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