INTERNA® NARROW IMPLANT CA D:3.5 L:11.5 IIPECA3511Recalls & reported problems
Biotechnology Institute Sl · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08435389813200), received between Nov 7, 2024 and Sep 15, 2026 — classified as 12 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate8
- Loss of Osseointegration4
Patient problems
- Unspecified Infection7
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 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. In the event the patient experienced: infection.
Patient problems: Unspecified Infection
MAUDE report 50770265 ↗InjuryApr 24, 2026Failure to Osseointegrate
THE CLINICIAN INDICATES THAT SHE/HE PLACED THE IMPLANT ON (B)(6) 2026 AND 2 MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. 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 24979090 ↗InjuryApr 24, 2026Failure to Osseointegrate
THE CLINICIAN INDICATES THAT SHE/HE PLACED THE IMPLANT ON (B)(6) 2026 AND 2 MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. 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 24979089 ↗InjuryApr 1, 2026Loss of Osseointegration
THE CLINICIAN INDICATES THAT SHE/HE PLACED THE IMPLANT ON (B)(6) 2025 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 24754815 ↗InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2025 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 23756478 ↗InjuryMar 3, 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 II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21502938 ↗InjuryDec 26, 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 II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21018432 ↗InjuryDec 10, 2024Failure 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 LL. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20892023 ↗InjuryNov 20, 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.
Patient problems: Unspecified Infection
MAUDE report 20732395 ↗InjuryNov 18, 2024Failure 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 IV. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703961 ↗InjuryNov 18, 2024Failure 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 I. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20703904 ↗InjuryNov 7, 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 20627739 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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