SURGIFLO¿ HAEMOSTATIC MATRIX

Additional Manufacturer Narrative

NO LOT NUMBER IS AVAILABLE.

Description of Event or Problem

THE PURPOSE OF THIS RANDOMIZED CONTROLLED TRIAL WAS TO COMPARE SURGIFLO HEMOSTATIC MATRIX USED WITH THROMBIN AND FUKANGSEN SPONGE TO FUKANGSEN SPONGE ALONE IN THE REDUCTION OF INTRAOPERATIVE BLOOD LOSS (IBL) IN UNILATERAL OPEN-DOOR LAMINOPLASTY. ADVERSE EVENTS ASSOCIATED WITH THE SURGICAL STRATEGY, INCLUDING C5 PALSY, AXIAL PAIN, HEMATOMA DEVELOPMENT, AND DELAYED WOUND HEALING WERE RECORDED AND MONITORED FOR 4 WEEKS AFTER DISCHARGE. IN ADDITION, THE TOTAL DRAINAGE VOLUME, DAYS OF DRAINAGE, AND LENGTH OF STAY WERE ALSO COLLECTED. THE STUDY SHOWED THAT IBL WAS REDUCED AND TIME-TO-HEMOSTASIS SHORTER IN THE SURGIFLO HEMOSTATIC MATRIX USED WITH THROMBIN + FUKANGSEN GROUP COMPARED TO FUKANGSEN ALONE. THIS IS NOT SURPRISING SINCE SURGIFLO HEMOSTATIC MATRIX IS USED WITH THROMBIN THUS IT IS MORE EFFECTIVE IN ACHIEVING HEMOSTASIS. NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN THE OTHER INTRAOPERATIVE PARAMETERS. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE LENGTH OF HOSPITAL STAY OR THE INCIDENCE OF ADVERSE EVENTS ASSOCIATED WITH THE SURGICAL STRATEGY BETWEEN THE 2 GROUPS. IN THE ARTICLE A TABLE INCLUDES N=3 PATIENTS EXPERIENCING C5 PALSY AND N=5 PATIENTS EXPERIENCING AXIAL PAIN IN THE SURGIFLO HEMOSTATIC MATRIX USED WITH THROMBIN GROUP. THE N=3 AND N=5 CASES OF C5 PALSY AND AXIAL PAIN RESPECTIVELY ARE INCLUDED IN QMS. NO ADDITIONAL ISSUES REGARDING SAFETY, EFFECTIVENESS, OR PERFORMANCE ARE IDENTIFIED FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

NO LOT NUMBER IS AVAILABLE. THE FOLLOW-UP INFORMATION STATES THAT THE EVENTS MENTIONED IN THE LITERATURE ARE NOT RELATED TO THE USE OF SURGIFLO. THUS, THE CASES ARE CONSIDERED WITH NO CAUSAL RELATIONSHIP TO SURGIFLO.

Description of Event or Problem

THE PURPOSE OF THIS RANDOMIZED CONTROLLED TRIAL WAS TO COMPARE SURGIFLO HEMOSTATIC MATRIX USED WITH THROMBIN AND FUKANGSEN SPONGE TO FUKANGSEN SPONGE ALONE IN THE REDUCTION OF INTRAOPERATIVE BLOOD LOSS (IBL) IN UNILATERAL OPEN-DOOR LAMINOPLASTY. ADVERSE EVENTS ASSOCIATED WITH THE SURGICAL STRATEGY, INCLUDING C5 PALSY, AXIAL PAIN, HEMATOMA DEVELOPMENT, AND DELAYED WOUND HEALING WERE RECORDED AND MONITORED FOR 4 WEEKS AFTER DISCHARGE. IN ADDITION, THE TOTAL DRAINAGE VOLUME, DAYS OF DRAINAGE, AND LENGTH OF STAY WERE ALSO COLLECTED. THE STUDY SHOWED THAT IBL WAS REDUCED AND TIME-TO-HEMOSTASIS SHORTER IN THE SURGIFLO HEMOSTATIC MATRIX USED WITH THROMBIN + FUKANGSEN GROUP COMPARED TO FUKANGSEN ALONE. THIS IS NOT SURPRISING SINCE SURGIFLO HEMOSTATIC MATRIX IS USED WITH THROMBIN THUS IT IS MORE EFFECTIVE IN ACHIEVING HEMOSTASIS. NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN THE OTHER INTRAOPERATIVE PARAMETERS. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE LENGTH OF HOSPITAL STAY OR THE INCIDENCE OF ADVERSE EVENTS ASSOCIATED WITH THE SURGICAL STRATEGY BETWEEN THE 2 GROUPS. IN THE ARTICLE A TABLE INCLUDES N=3 PATIENTS EXPERIENCING C5 PALSY AND N=5 PATIENTS EXPERIENCING AXIAL PAIN IN THE SURGIFLO HEMOSTATIC MATRIX USED WITH THROMBIN GROUP. THE N=3 AND N=5 CASES OF C5 PALSY AND AXIAL PAIN RESPECTIVELY ARE INCLUDED IN QMS. NO ADDITIONAL ISSUES REGARDING SAFETY, EFFECTIVENESS, OR PERFORMANCE ARE IDENTIFIED FOR FURTHER EVALUATION. FOLLOW-UP INFORMATION WAS RECEIVED STATING: · PLEASE ELABORATE IF THE EVENTS OF PALSY AND PAIN IS CONSIDERED RELATED TO SURGIFLO OR THE SURGERY PER SE. --THE EVENTS MENTIONED IN THE LITERATURE ARE NOT RELATED TO THE SURGIFLO USED. · PLEASE ELABORATE WHICH TYPE OF THROMBIN IS USED WITH SURGIFLO SINCE ONLY SURGIFLO WITHOUT THROMBIN IS MARKETED IN CHINA. · PLEASE ELABORATE IF THE "PAIN" EVENTS WERE TREATED AND HOW. PLEASE PROVIDE COMPLAINT REFERENCE NUMBERS. · PLEASE PROVIDE EVENT DETAILS FOR EACH PATIENT INCLUDING: - INITIAL PROCEDURE DATE - PROCEDURE NAME - SPECIFIC PATIENT DEMOGRAPHICS - WHERE WAS THE PROCEDURE PERFORMED? - EVENT DATE - SPECIFIC MEDICAL/SURGICAL INTERVENTION - SURGIFLO PRODUCT INVOLVED (PRODUCT CODE AND LOT NUMBER) - PATIENT PRE-EXISTING CONDITIONS/OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS - ARE ANY DEVICES AVAILABLE FOR EVALUATION? --CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO THE EVENT DESCRIPTION. OTHER INFORMATION REQUESTED IS UNKNOWN. THE FOLLOW-UP INFORMATION STATES THAT THE EVENTS MENTIONED IN THE LITERATURE ARE NOT RELATED TO THE USE OF SURGIFLO. THUS, THE CASES ARE CONSIDERED WITH NO CAUSAL RELATIONSHIP TO SURGIFLO.