TINY® IMPLANT CA D:3.3 L:10 IRTCA3310Recalls & reported problems
Biotechnology Institute Sl · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435389812821), received between Nov 5, 2024 and Jun 26, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024- AND 4-MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: BONE LOSS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22335013 ↗InjuryNov 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2021 AND 4-MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION, BONE LOSS AND PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 20609100 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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