UNIVERSAL PLATFORM IMPLANT CA D:3.75 L:10 IRPUCA3710Recalls & 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 08435389815136), received between Jul 3, 2024 and Jan 7, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate3
- Loss of Osseointegration2
Patient problems
- Unspecified Infection5
- Bruxism1
- Inflammation1
- Pain1
Recent adverse event reports
The 5 most recent of 5 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) 2023 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21092060 ↗InjuryDec 26, 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 IV. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21018422 ↗InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2021 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 INFLAMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 20576115 ↗InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2021 AND ONE DAY LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Bruxism; Unspecified Infection
MAUDE report 19761617 ↗InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2020 AND, DURING THE SECOND SURGERY (TWO MONTHS LATER) IT WAS OBSERVED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH A BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 19666520 ↗
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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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