EXTERNA® UNIVERSAL PLUS IMPLANT CA D:4.5 L:10 IRPSCA4510Recalls & 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 08435389814993), received between Nov 19, 2024 and Mar 3, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 Osseointegration2
- Failure to Osseointegrate1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN INDICATES THAT SHE 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 21502940 ↗InjuryFeb 26, 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 II. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21468700 ↗InjuryDec 10, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2018 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY LLL. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND PERIIMPLANTITIS.
Patient problems: Unspecified Infection
MAUDE report 20892187 ↗InjuryNov 19, 2024Fracture; Fracture
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024 AND, 5 YEARS AND 8 MONTHS LATER, IT WAS VERIFIED THAT THE IMPLANT WAS BROKEN. 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 20721545 ↗
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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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