INTERNA® PLUS UNIVERSAL IMPLANT CA D:4.5 L:7.5 IIPSCA4575Recalls & reported problems
Biotechnology Institute Sl · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08435389811824), received between Jan 7, 2025 and Jan 23, 2025 — classified as 5 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4
- Loss of Osseointegration1
Patient problems
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2016 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: PERIIMPLANTITIS.
Patient problems: Unspecified Infection
MAUDE report 21217267 ↗InjuryJan 23, 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 III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21217256 ↗InjuryJan 23, 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 IV. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21215942 ↗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 III. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092096 ↗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 III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21092066 ↗
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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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