INTERNA® PLUS UNIVERSAL IMPLANT CA D:5 L:6.5 IIPSCA5065Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08435389811893), received between Jul 3, 2024 and Mar 2, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Loss of Osseointegration

  THE CLINICIAN INDICATES THAT SHE/HE PLACED THE IMPLANT ON (B)(6) 2023 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY II. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481800 ↗
• InjuryOct 22, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024 AND LOSS OF OSSEOINTEGRATION OCCURS. 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 23355976 ↗
• InjuryJan 23, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024 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 21217272 ↗
• InjuryDec 26, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2023- AND 2-MONTHS 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 21018413 ↗
• InjuryJul 22, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2021 AND ONE MONTHS 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 19793145 ↗
• InjuryJul 22, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE DETECTS THAT THE IMPLANT HAS NOT OSSEOINTEGRATED. PATIENT WITH A BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Bruxism; Unspecified Infection

  MAUDE report 19792813 ↗
• InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2020- AND ONE-MONTH LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY IV. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19666617 ↗