OPRA Implant System 1804Recalls & reported problems
Integrum AB · Fixture BioHelix 18x80-12 · Class 3 · 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 07340152100214), received between Jun 16, 2025 and Aug 31, 2026 — 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
- Adverse Event Without Identified Device or Use Problem3
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration3
- Unspecified Infection2
- Implant Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
Fixture removal surgery due to Fixture loosening. The procedure took place on (b)(6), 2026.
Patient problems: Inadequate Osseointegration
MAUDE report 50515578 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
FIXTURE REMOVAL SURGERY DUE TO DEEP INFECTION. NO CLINICAL SIGNS REPORTED. THE PROCEDURE TOOK PLACE (B)(6) 2026.
Patient problems: Unspecified Infection
MAUDE report 24688217 ↗InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
FIXTURE REMOVAL SURGERY DUE TO DEEP INFECTION AND ASEPTIC LOOSENING. PAIN WAS REPORTED AS CLINICAL SIGNS. THE PROCEDURE TOOK PLACE IN (B)(6) 2025.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23485516 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIXTURE REMOVAL SURGERY DUE TO ASEPTIC LOOSENING. THE PROCEDURE TOOK PLACE ON (B)(6) 2025.
Patient problems: Inadequate Osseointegration
MAUDE report 22211226 ↗
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 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 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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