INTERNA® UNIVERSAL IMPLANT CA D:4 L:11.5 IIPUCA4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08435389812210), received between Jul 3, 2024 and Feb 11, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2025 AND IN THE SAME MONTH IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY IV. IN THE EVENT THE PATIENT EXPERIENCED: BONE LOSS AND PAIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 24312058 ↗
• InjuryDec 27, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2023 AND IN THE SAME MONTH IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21025989 ↗
• InjuryDec 26, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2023- AND 1-MONTH LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21018426 ↗
• InjuryDec 26, 2024Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2022 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21018416 ↗
• InjuryJul 16, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2020 AND, DURING THE SECOND SURGERY (FOUR MONTHS LATER) IT WAS OBSERVED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND MOUTH SORE.

  Patient problems: Unspecified Infection

  MAUDE report 19750342 ↗
• InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT DURING THE RADIOLOGICAL EXAMINATION PERFORMED ONE AND A HALF MONTHS AFTER SURGERY HE NOTICED THAT THE IMPLANT HAS NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19663398 ↗