LIQUIFIX PRECISION¿ OPEN

Additional Manufacturer Narrative

THE ADVERSE EVENT WAS RECEIVED AS PART OF THE US POST APPROVAL STUDY (PAS). DETAILS RECEIVED FROM THE ACHQC WERE: '1 SURGICAL SITE INFECTION TIME: WITHIN 30D OF SURGERY DEVICE: LIQUIFIX PRECISION 72014033 LOCATION: USA'. NO FURTHER INFORMATION WAS AVAILABLE. AS PER FDA 21 CFR 803.3, A 'SERIOUS INJURY' IS DEFINED AS: 'AN INJURY OR ILLNESS THAT: IS LIFE THREATENING. RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.' AMS CANNOT CONCLUDE THAT THIS CLINICAL ADVERSE EVENT WAS DEVICE-RELATED. ALTHOUGH NO MEDICAL INTERVENTION WAS CONFIRMED, INFECTION IS A COMPLICATION THAT LIKELY REQUIRES MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THEREFORE, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY AND IS BEING REPORTED IN THE USA AS A PRECAUTIONARY MEASURE.

Description of Event or Problem

MFR REPORT #: 9617175-2025-00014. THE ADVERSE EVENT WAS RECEIVED AS PART OF THE US POST APPROVAL STUDY (PAS). DETAILS RECEIVED FROM THE ACHQC WERE: '1 SURGICAL SITE INFECTION. TIME: WITHIN 30D OF SURGERY DEVICE: LIQUIFIX PRECISION 72014033. LOCATION: USA' NO FURTHER INFORMATION WAS AVAILABLE.