INTERNA® NARROW IMPLANT CA D:4 L:7.5 IIPECA4075Recalls & reported problems
Biotechnology Institute Sl · Class 2 · Implant
Data updated Oct 18, 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 08435389820765), received between Mar 24, 2025 and Jun 22, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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
- Failure to Osseointegrate1
- Loss of Osseointegration1
Patient problems
- Inflammation1
- 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 22, 2026Loss of Osseointegration
THE CLINICIAN INDICATES THAT SHE/HE PLACED THE IMPLANT ON (B)(6) 2025 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: PAIN.
Patient problems: Pain
MAUDE report 25573996 ↗InjuryMar 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN INDICATES THAT SHE PLACED THE IMPLANT ON (B)(6) 2025 AND 1 MONTH LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 21675234 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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