INTERNA® PLUS UNIVERSAL IMPLANT CA D:5 L:5.5 IIPSCA5055Recalls & reported problems
Biotechnology Institute Sl · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08435389811886), received between Jul 23, 2024 and Dec 27, 2024 — classified as 3 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
Patient problems
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 27, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN INDICATES THAT SHE PLACED THE IMPLANT ON (B)(6) 2022 AND LOSS OF OSSEOINTEGRATION OCCURS. PATIENT WITH BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION, BONE LOSS AND SUPURATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 21025994 ↗InjuryNov 18, 2024Loss 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: BONE LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703900 ↗InjuryJul 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2021 AND ONE MONTH LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY IV. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19806515 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page