INTERNA® UNIVERSAL IMPLANT CA D:4 L:10 IIPUCA4010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08435389812203), received between Jul 2, 2024 and Dec 29, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2018 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY I. IN THE EVENT THE PATIENT EXPERIENCED: BONE LOSS.

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

  MAUDE report 23904413 ↗
• InjuryMar 3, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024- AND 3-MONTHS LATER 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 21504040 ↗
• InjuryJan 23, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT SHE PLACED THE IMPLANT ON (B)(6) 2019 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY IV. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215941 ↗
• InjuryJan 7, 2025Failure 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 21092067 ↗
• InjuryJan 7, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT SHE PLACED THE IMPLANT ON (B)(6) 2023- AND 2-MONTHS LATER 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 21091318 ↗
• InjuryDec 26, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2023 AND1 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 21018423 ↗
• InjuryDec 4, 2024Failure 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843577 ↗
• InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT SHE PLACED THE IMPLANT ON (B)(6) 2022 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: BONE LOSS AND MUCOSITIS.

  Patient problems: Inflammation

  MAUDE report 20704427 ↗
• InjuryNov 18, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024 AND 2-MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20704402 ↗
• InjuryJul 8, 2024Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Bruxism; Inflammation; Pain; Unspecified Infection

  MAUDE report 19689439 ↗
• InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2020 AND TWO MONTHS LATER 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 19665926 ↗
• InjuryJul 3, 2024Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2017 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH A BONE QUALITY I. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND BONE LOSS.

  Patient problems: Unspecified Infection

  MAUDE report 19663444 ↗
• InjuryJul 2, 2024Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2019 AND, AFTER PLACING THE DEFINITIVE PROSTHESIS (6 MONTHS LATER), THE IMPLANT LOSES OSSEOINTEGRATION AFTER ONE WEEK. PATIENT WITH A BONE QUALITY BETWEEN III AND IV. IN THE EVENT THE PATIENT EXPERIENCED: VESTIBULAR FISTULA.

  Patient problems: Fistula

  MAUDE report 19655084 ↗