INTERNA® UNIVERSAL PLUS IMPLANT CA D:4.5 L:10 IIPSCA4510Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08435389811763), received between Jul 5, 2024 and Feb 11, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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.

• InjuryFeb 11, 2026Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024 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 24312080 ↗
• InjuryJan 23, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2023 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21217268 ↗
• InjuryJan 23, 2025Failure 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 21217266 ↗
• InjuryJan 23, 2025Failure 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 21217261 ↗
• InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Bruxism; Unspecified Infection

  MAUDE report 19761678 ↗
• InjuryJul 16, 2024Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Unspecified Infection

  MAUDE report 19750344 ↗
• InjuryJul 5, 2024Fracture; Fracture

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2018 AND, A YEAR AND A HALF LATER, IT WAS VERIFIED THAT THE IMPLANT WAS BROKEN. PATIENT WITH BONE QUALITY III. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.

  Patient problems: Bruxism

  MAUDE report 19679265 ↗