LIQUIFIX PRECISION OPEN

Description of Event or Problem

MFR REPORT #: 9617175-2025-00022 THIS EVENT WAS RECEIVED AS PART OF A POST APPROVAL STUDY IN THE USA. 6. 1 REOPERATION FOR RECURRENCE. A. TIME: 1 YEAR FOLLOW UP B. DEVICE: LIQUIFIX PRECISION 72014033 C. LOCATION: USA DUE TO THE NATURE OF HOW THIS DATA IS RETROSPECTIVELY COLLECTED VIA THE ACHQC REGISTRY, NO FURTHER INFORMATION IS PROVIDED FOR THIS CASE.

Additional Manufacturer Narrative

MFR REPORT #: 9617175-2025-00022. THIS EVENT WAS RECEIVED AS PART OF A POST APPROVAL STUDY IN THE USA. 6. 1 REOPERATION FOR RECURRENCE. A. TIME: 1 YEAR FOLLOW UP B. DEVICE: LIQUIFIX PRECISION 72014033 C. LOCATION: USA. DUE TO THE NATURE OF HOW THIS DATA IS RETROSPECTIVELY COLLECTED VIA THE ACHQC REGISTRY, NO FURTHER INFORMATION IS PROVIDED FOR THIS CASE. 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 ADVERSE EVENT WAS DEVICE-RELATED. HOWEVER, AS THIS EVENT REQUIRED SURGICAL INTERVENTION, IN THE FORM OF REOPERATION, TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY AND IS BEING REPORTED IN THE USA.