OPRA Implant System 1808Recalls & reported problems
Integrum AB · Fixture BioHelix 20x80-12 · Class 3 · 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 07340152100252), received between Sep 11, 2025 and Apr 10, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Fracture1
Patient problems
- Inadequate Osseointegration2
- 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.
InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
FIXTURE REMOVAL DUE TO ASEPTIC LOOSENING AND THE PATIENT'S OWN WISHES. THE SURGERY TOOK PLACE (B)(6) 2026.
Patient problems: Inadequate Osseointegration
MAUDE report 24842480 ↗InjurySep 11, 2025Fracture; Fracture
FIXTURE REMOVAL SURGERY OF A FRACTURED FIXTURE DUE TO TRAUMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026173 ↗InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIXTURE REMOVAL DUE TO ASEPTIC LOOSENING AND THE PATIENT'S OWN WISHES.
Patient problems: Inadequate Osseointegration
MAUDE report 23026172 ↗
Other Transfemoral Percutaneous Prosthetic devices
- OPRA Implant System 1288Integrum AB · Transfemoral Percutaneous Prosthetic109 reports
- OPRA Implant System 1820Integrum AB · Transfemoral Percutaneous Prosthetic8 reports
- OPRA Implant System 1804Integrum AB · Transfemoral Percutaneous Prosthetic4 reports
- OPRA Implant System 1800Integrum AB · Transfemoral Percutaneous Prosthetic4 reports
- OPRA Implant System 1803Integrum AB · Transfemoral Percutaneous Prosthetic2 reports
- OPRA Implant System 1811Integrum AB · Transfemoral Percutaneous Prosthetic2 reports
- OPRA Implant System 1810Integrum AB · Transfemoral Percutaneous Prosthetic2 reports
- OPRA Implant System IBC0010Integrum AB · Transfemoral Percutaneous Prosthetic2 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.
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