OPRA Implant System 1811Recalls & reported problems
Integrum AB · Fixture BioHelix 23x80-12 · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07340152100283), received between Nov 7, 2018 and Mar 12, 2026 — classified as 2 injuries.
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
Patient problems
- Bone Fracture(s)1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem
SURGERY FOR FIXTURE REMOVAL FROM TIBIA DUE TO SKELETAL FRACTURE. PAIN WHEN LOADING REPORTED AS CLINICAL SIGN. THE PROCEDURE TOOK PLACE ON (B)(6) 2026.
Patient problems: Bone Fracture(s)
MAUDE report 24581298 ↗InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIXTURE LOOSENING. NO DEVIATION IN BATCH DOCUMENTATION. ACCORDING TO REPORT FORM THE CAUSE OF FAILURE IS UNKNOWN. NO FURTHER INVESTIGATION.
Patient problems: No Code Available
MAUDE report 8048127 ↗
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 1808Integrum AB · Transfemoral Percutaneous Prosthetic3 reports
- OPRA Implant System 1803Integrum 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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