UNIVERSAL PLATFORM IMPLANT CA D:3.75 L:11.5 IRPUCA3711Recalls & reported problems
Biotechnology Institute Sl · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08435389815143), received between Dec 10, 2024 and Jan 7, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (3 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
- Loss of Osseointegration3
- Failure to Osseointegrate1
Patient problems
- Unspecified Infection4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2025Loss 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 I. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21092076 ↗InjuryJan 7, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2015 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERIIMPLANTITIS AND BONE LOSS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 21092074 ↗InjuryJan 7, 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 II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21092058 ↗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 LL. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20892107 ↗
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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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