INTERNA® NARROW IMPLANT CA D:3.5 L:7.5 IIPECA3575Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08435389813484), received between Nov 4, 2024 and Jul 8, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2026 AND 4 MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25745145 ↗
• InjuryMar 2, 2026Loss of Osseointegration

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2025 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY I. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481565 ↗
• InjuryFeb 11, 2026Loss of Osseointegration

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

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

  MAUDE report 24312079 ↗
• InjuryFeb 11, 2026Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2025 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 AND INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 24312075 ↗
• InjuryApr 29, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN INDICATES THAT SHE 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 21924237 ↗
• InjuryMar 3, 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 III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21502946 ↗
• InjuryJan 7, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2023- AND 3-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 21092061 ↗
• InjuryJan 7, 2025Failure 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 II. IN THE EVENT THE PATIENT EXPERIENCED: BONE LOSS.

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

  MAUDE report 21090048 ↗
• InjuryDec 10, 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 LV. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20892153 ↗
• InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT SHE PLACED THE IMPLANT ON (B)(6)2024 AND IN THE SAME MONTH IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843617 ↗
• InjuryNov 4, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2022- AND 3-MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY IV. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND FISTULA.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 20596714 ↗