EASYNJECT

Description of Event or Problem

ON 05 MAY 2026, OUR DISTRIBUTOR (B)(4) (VIA REPRESENTATIVE MS. (B)(4)) NOTIFIED OUR CUSTOMER CARE DEPARTMENT OF AN ADVERSE EVENT INVOLVING THE EASYNJECT DEVICE (REF. CODE: (B)(4), LOT: 25072145). THE INITIAL NOTIFICATION STATED: "I HAVEN'T RECEIVED ANY NEGATIVE SIDE EFFECTS FROM THE PATIENT AND THANKFULLY THE SURGEON NOTICED THE CEMENT IN THE SPINAL CORD IN THE FILMS WHILE IN SURGERY." THE EMAIL FROM (B)(4) INCLUDED THE FOLLOWING DETAILS PROVIDED BY THE HOSPITAL WHERE THE INCIDENT OCCURRED: (B)(6). · REPORTED FRIDAY BY REP (B)(6) TO CONTACT PHYSICIAN, (B)(6). PHYSICIAN AND I CALLED BACK-AND-FORTH BETWEEN (B)(6) AND (B)(6). FINALLY CONNECTED (B)(6) OVER THE PHONE 7PM. THE DOCTOR BELIEVES THAT THE KVT GUN HAD TOO MUCH PRESSURE TO INJECT. THE PATIENT DID HAVE CANAL COMPRESSION AND HAD TO BE MONITORED. NO OTHER PERSON IN THE ROOM WAS AFFECTED. PATIENT DID NOT HAVE MORTALITY ONLY COMPLICATION. 3-D SPIN IMAGES ATTACHED. THE PHYSICAL PRODUCT DID NOT MALFUNCTION DURING THE CASE. THE CEMENT WAS INJECTED AFTER WAITING FIVE MINUTES POST MIXING WITH INJECTION BETWEEN EIGHT AND 10 MINUTES. THE PREVIOUS TWO LEVELS UTILIZED ONE BATCH OF CEMENT, AND THE THIRD LEVEL UTILIZED A SECOND BATCH OF CEMENT. THE SECOND BATCH IS WHAT SEEMED TO HAVE LEAKED ON LEVEL 3 AFTER WAITING OVER 5-8 MINUTES POST MIXING. THE TROCARS WERE BEYOND THE POSTERIOR THIRD AND IN BIPEDICULAR SETUP. THE SURGEON DOES NOT WANT TO USE Z-PLASTY MOVING FORWARD AND FEELS THAT WE NEED TO INVESTIGATE THE CEMENT GUN WHICH IS MANUFACTURED BY BIOPSY BELL. ON 07 MAY 2026: BIOPSYBELL ISSUED FORM 171 ("INITIAL INVESTIGATION OF COMPLAINT") TO (B)(4) TO GATHER THE NECESSARY DATA REQUIRED TO PROCEED WITH THE INTERNAL INVESTIGATION. ON 11 AND 12 MAY 2026: BIOPSYBELL SENT FORMAL REMINDERS TO (B)(4), AS NO RESPONSE TO FORM 171 HAD BEEN RECEIVED. ON 13 MAY 2026: BIOPSYBELL RECEIVED THE COMPLETED FORM 171 FROM (B)(4), CONTAINING THE COMPREHENSIVE INFORMATION AND RESPONSES REQUIRED TO ADDRESS THE QUESTIONS SUBMITTED FOR THE INVESTIGATION. DETAILS OF THE FORM 171: PRIVATE FACILITY: (B)(6). PRODUCT NAME: EASYNJECT . CODE: KVTGUN-DS1 . BATCH: 25072145. UDI: (B)(4). EXPIRY DATE: 07/07/30. NUMBER OF COMPLAINED PIECES: 1 . NUMBER OF COMPLAINED PIECES AVAILABLE: 0 . OTHER PIECES IN STOCK OF THE SAME LOT: REQUESTED. DATE OF THE EVENT: (B)(6) 26. PATIENT DATA: NOT AVAILABLE, BUT REQUESTED. CLINICAL CONDITIONS: CANAL COMPRESSION RESULTS OF THE PROCEDURE PERFORMED: MAY PERFORM REVISION IF BELOW AE DON'T SUBSIDE TINGLING AND SLIGHT PAIN IN LEGS. THE PATIENT'S CLINICAL CONDITION AND DATA AND THE AVAILABILITY OF ANY REMAINING UNITS FROM THE AFFECTED BATCH ARE TWO MATTERS CURRENTLY UNDER REVIEW. WE ARE IN CONTACT WITH OUR DISTRIBUTOR, WHO IN TURN IS IN CONTACT WITH THE PHYSICIAN AND THE HOSPITAL TO GATHER THE REQUESTED INFORMATION. DETAILS AND ANSWERS: PATIENT STATUS & CLINICAL CONFIRMATION: REGARDING THE ASSUMPTIONS IN YOUR EMAIL, PLEASE NOTE THE FOLLOWING UPDATES WHICH CLARIFY THE PATIENT'S CONDITION: NEUROLOGICAL STATUS: CONTRARY TO PREVIOUS ASSUMPTIONS, THE PATIENT HAS EXPERIENCED SIGNIFICANT TINGLING AND SLIGHT PAIN IN THE LEGS FOLLOWING THE PROCEDURE. INTERVENTION: THE PHYSICIAN IS CURRENTLY FOLLOWING UP WITH THE PATIENT TO MONITOR THESE SYMPTOMS. A DETERMINATION HAS NOT YET BEEN MADE AS TO WHETHER THE TINGLING WILL SUBSIDE OR IF ADDITIONAL SURGICAL INTERVENTION WILL BE REQUIRED TO ADDRESS THE CEMENT LEAK. CONFIRMATION: BECAUSE THE CLINICAL OUTCOME IS STILL PENDING, WE CANNOT CONFIRM AT THIS TIME THAT THERE IS NO PERMANENT HARM OR NEUROLOGICAL DEFICIT. WE WILL PROVIDE UPDATES AS THE PHYSICIAN SHARES THEM WITH US. DEVICE AND LOT INFORMATION: OTHER DEVICES FROM LOT 25072145: WE HAVE REQUESTED INFORMATION FROM THE SALES REPRESENTATIVE REGARDING WHETHER THESE WERE USED BY THE SAME PHYSICIAN/HOSPITAL AND THE OUTCOMES OF THOSE PROCEDURES. WE ARE ALSO VERIFYING CURRENT STOCK LEVELS FOR THIS LOT. WE WILL FORWARD THESE DETAILS AS SOON AS THEY ARE RECEIVED. CEMENT LOTS: IT IS CONFIRMED THAT THE PHYSICIAN USED THE SAME LOT NUMBER OF CEMENT FOR ALL THREE LEVELS, BUT THE LEAK OCCURRED ONLY ON THE THIRD LEVEL. GUN LOT: WE CONFIRM THAT THE SAME GUN LOT (25072145) WAS USED FOR ALL THREE LEVELS OF THE PROCEDURE.

Additional Manufacturer Narrative

FOLLOWING RECEIPT OF THE COMPLAINT, AN INTERNAL INVESTIGATION WAS LAUNCHED, INCLUDING A COMPLETE ASSESSMENT OF THE TRACEABILITY OF THE BATCH INVOLVED, THE PARTS SOLD ON THE MARKET, THE RAW MATERIALS USED, THE QUALITY CONTROLS PERFORMED AND THE PRODUCTION PROCEDURES FOLLOWED. PRODUCTION-RELATED ASPECTS WERE THOROUGHLY EVALUATED AND NO PROBLEMS WERE FOUND DURING THE QUALITY CONTROLS CARRIED OUT DURING AND AT THE END OF PRODUCTION. THE DOCUMENTATION RELATING TO THE PRODUCTION PROCESS OF THE BATCH IN QUESTION WAS EXAMINED AND NO ANOMALIES OR DEFECTS WERE FOUND. ALL COMPLETED PROCESS RECORDS WERE CHECKED TO SEE IF ANY NON-CONFORMITIES HAD BEEN DETECTED DURING ROUTINE CHECKS, BUT NONE WERE REPORTED. FURTHER ASSESSMENTS WERE CARRIED OUT ON THE HISTORICAL DATA OF THE PRODUCT, BOTH FROM A PRODUCTION AND COMMERCIAL POINT OF VIEW. FROM A PRODUCTION POINT OF VIEW, IT SHOULD BE NOTED THAT NO CHANGES WERE MADE TO THE MATERIALS, COMPONENTS OR CONTROL PROCEDURES. INTERNAL OPERATING AND QUALITY CONTROL PROCEDURES HAVE REMAINED ESSENTIALLY UNCHANGED OVER TIME, AND MATERIAL SPECIFICATIONS HAVE REMAINED CONSISTENT. FROM A COMMERCIAL STANDPOINT, IT IS IMPORTANT TO NOTE THAT NO OTHER CUSTOMER HAS REPORTED SIMILAR PROBLEMS WITH FINISHED PRODUCT BATCH. WE HAVE CHECKED THE INVENTORY OF THE AFFECTED BATCH (25072145) AND THE BATCH OF SEMI-FINISHED PRODUCTS USED, AND UNFORTUNATELY THERE ARE NO PARTS AVAILABLE FOR INSPECTION AND/OR TESTING. THE DISTRIBUTOR ZAVATION MUST CONFIRM WHETHER UNITS FROM THE AFFECTED LOT ARE STILL AVAILABLE AT THEIR WAREHOUSE AND/OR THE HOSPITAL'S WAREHOUSE. AFTER ANALYZING ALL THE INFORMATION RECEIVED, WE CAN CONFIRM THAT THE PROCEDURE INVOLVED 3 LEVELS, MEANING 3 VERTEBRAE WERE TREATED. THE ISSUE OCCURRED AT THE LAST LEVEL; IN THE TWO PREVIOUS LEVELS, THE SAME BATCH OF OUR DEVICE (KVTGUN-DS1 LOT 25072145) WAS USED, AND NO ANOMALIES WERE OBSERVED, AND THE PROCEDURE WAS PERFORMED CORRECTLY. THIS DEMONSTRATES THAT THE FIRST TWO DEVICES WERE FOUND TO BE COMPLIANT WITH THE INTENDED USE; THEREFORE, THE HYPOTHESIS OF A MANUFACTURING DEFECT CAUSING THE DEVICE MALFUNCTION CAN BE RULED OUT. ANOTHER ASPECT TO CONSIDER IS THE USE OF AN ADDITIONAL COMPONENT (NOT MANUFACTURED BY OUR ORGANIZATION) THAT IS USED DURING THE PROCEDURE: CEMENT. THE PREPARATION OF THE CEMENT FOR INJECTION HAS BEEN IDENTIFIED AS A POTENTIALLY CRITICAL PHASE OF THE PROCESS (KHYPHOPLASTY PROCEDURE), AS IT REQUIRES ADHERENCE TO SPECIFIC PROCESSING TIMES, EXPRESSED IN MINUTES, AS WELL AS EXECUTION UNDER CONTROLLED ENVIRONMENTAL CONDITIONS, PARTICULARLY WITH REGARD TO TEMPERATURE. BASED ON THE ABOVE, AS PART OF THE INVESTIGATION INTO THE COMPLAINT, IT IS CONSIDERED RELEVANT TO SHIFT THE FOCUS TO THE EVALUATION OF THE CEMENT PREPARATION. IF THIS STEP WAS NOT PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) PROVIDED BY THE RESPECTIVE MANUFACTURER AND IF THE CONSISTENCY WAS NOT APPROPRIATE AND SUITABLE FOR THE INTENDED USE, IT CANNOT BE RULED OUT THAT THIS STEP WAS A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED EVENT. IN LIGHT OF THE ABOVE CONSIDERATIONS, GIVEN THE IMPOSSIBILITY OF DETERMINING THE CAUSE OF THE IDENTIFIED PROBLEM AND THE FACT THAT THE INVESTIGATIONS CONDUCTED DID NOT REVEAL ANY MANUFACTURING DEFECTS, ANOMALIES RELATED TO THE RAW MATERIALS USED, OR ISSUES DURING THE INSPECTION AND VERIFICATION PHASES, THE EVENT CAN REASONABLY BE CONSIDERED AN ISOLATED CASE POTENTIALLY ATTRIBUTABLE TO CONDITIONS OF USE AND ATTRIBUTABLE TO EXTERNAL FACTORS, NOT TO THE DEVICE'S DESIGN AND/OR ANOMALIES IN THE MANUFACTURING PROCESS. DURING KYPHOPLASTY PROCEDURES, IT CAN BE CONFIRMED THAT POTENTIAL CEMENT LEAKAGE IS ONE OF THE RISKS ASSOCIATED WITH THE PROCEDURE ITSELF. AS INDICATED ABOVE AND BASED ON THE ASSESSMENTS CONDUCTED, ACCORDING TO THE DATA AND EVIDENCE CURRENTLY AVAILABLE, BIOPSYBELL CONCLUDES THAT THE MEDICAL DEVICE COVERED BY THIS TEST REPORT DOES NOT PRESENT ANY SAFETY OR PERFORMANCE ISSUES. CONSEQUENTLY, NO CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) OR FIELD SAFETY CORRECTIVE ACTIONS (FSCA) ARE CURRENTLY DEEMED NECESSARY.