OPRA Implant System 1800Recalls & reported problems
Integrum AB · Fixture BioHelix 16x80-12 · 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 07340152100177), received between Dec 19, 2018 and May 27, 2026 — classified as 4 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 Problem4
Patient problems
- Inadequate Osseointegration2
- Bacterial Infection1
- Implant Pain1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
FIXTURE REMOVAL SURGERY DUE TO INFECTION. THE PROCEDURE TOOK PLACE ON (B)(6) 2026.
Patient problems: Unspecified Infection
MAUDE report 25298891 ↗InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIXTURE REMOVAL SURGERY DUE TO PAIN AND FIXTURE LOOSENING. THE PROCEDURE TOOK PLACE ON (B)(6) 2025.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 23425111 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIXTURE REMOVAL SURGERY DUE TO SUSPECTED DEEP INFECTION (NOT CONFIRMED) OR ASEPTIC LOOSENING. PAIN WHEN LOADING AND OSTEOLYSIS WERE REPORTED AS CLINICAL SIGNS. THE PROCEDURE TOOK PLACE IN SWEDEN ON (B)(6) 2025.
Patient problems: Inadequate Osseointegration
MAUDE report 22211227 ↗InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIXTURE LOOSENING, DEEP INFECTION. PROBABLY CAUSE UNKNOWN ACCORDING TO SURGEON. AT SURGERY A BAD PRESSFIT IS DISCOVERED. PLAY BETWEEN COMPONENTS WITH TIGHTENED ABUTMENT SCREW. (B)(4). THE PRODUCT PERFORMANCE WILL NOT BE AFFECTED ACCORDING TO CONCESSION DOCUMENTATION.
Patient problems: Bacterial Infection
MAUDE report 8182324 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page