SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN

Additional Manufacturer Narrative

NO LOT NUMBER IS AVAILABLE.

Description of Event or Problem

SPINE TRAUMATOLOGIST SURGEON REPORTS DURING AN EDUCATIONAL ACTIVITY THAT AFTER USING SURGIFLO WITH THROMBIN IN ONE OF HIS LUMBAR FIXATION PROCEDURES, IT WAS NECESSARY TO REOPERATE THE PATIENT AFTER ENCOUNTERING SYMPTOMS OF NERVE COMPRESSION. THE CLINICAL FINDING DURING THE REOPERATION WAS VERY HARDENED REMAINS OF SURGIFLO THAT HAD TO BE METICULOUSLY REMOVED TO MITIGATE THE PATIENT'S SYMPTOMS. NO DEVICE IS AVAILABLE FOR EVALUATION. SURGIFLO/LYO THROMBIN KIT (MS0012) : AFFECTED SIDE: NOT APPLICABLE. REASON WHY THE PRODUCT IS NOT AVAILABLE: IMPLANTED. LIST THE J&J PRODUCTS THAT WERE USED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. UNKNOWN WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? YES DID THE PATIENT/USER REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT? YES_ DESCRIPTION REOPERATION TO REMOVE SOLIDIFIED REMAINS OF SURGIFLO, DID THE PATIENT/USER REQUIRE PROLONGED HOSPITALIZATION AS A RESULT OF THE EVENT? YES. DESCRIPTION 1 ADDITIONAL WEEK TO THE ONE INITIALLY SCHEDULED. WHAT IS THE PATIENT/USER STATUS AFTER THE EVENT? DISCHARGED AFTER PROLONGED POST-REOPERATION HOSPITALIZATION . WAS THERE A SIGNIFICANT DELAY? UNKNOWN IF AVAILABLE, PLEASE PROVIDE THE PRODUCT ORDER NUMBER (PO). PROCEDURE: (B)(6) 2026, EVENT DATE: 05/12/2026. ADDITIONAL INFORMATION WAS RECEIVED ON 27.05.2026 STATING: INDICATION FOR USE OF THE PRODUCT: HEMOSTASIS DURING LUMBAR FIXATION. ANATOMICAL LOCATION OF SURGIFLO APPLICATION: LUMBAR SPINE, INTERLAMINAR SPACE. SURGIFLO USAGE INDICATION: INTRAOPERATIVE HEMOSTASIS. AMOUNT OF SURGIFLO APPLIED: 8 ML. DID SURGIFLO WITHDRAW AFTER ACHIEVING HEMOSTASIS? TIMING OF ONSET OF NERVE COMPRESSION SYMPTOMS: DURING THE IMMEDIATE POSTOPERATIVE ASSESSMENT. WAS THE REMOVED MATERIAL ANALYZED? BATCH NUMBER: PATIENT DEMOGRAPHICS (INITIALS/ID, AGE OR DATE OF BIRTH, BMI, SEX, PRE-EXISTING MEDICAL CONDITIONS, CONCOMITANT MEDICATION, MEDICAL HISTORY, REQUIRED TREATMENTS, DOSAGE, FREQUENCY, AND DATES): SURGEON'S OPINION ON THE RELATIONSHIP OF THE PRODUCT TO THE SYMPTOMS: IT DIRECTLY RELATES THE CONSISTENCY OF SURGIFLO TO NERVE COMPRESSION. CURRENT PATIENT CONDITION: MEDICAL DISCHARGE.