SEPTOJECT

Description of Event or Problem

MFR REPORT #: FR-SEPTODONT-(B)(4) / 1. #1: NEEDLE BROKEN V28.1 (BROKEN AT THE PLASTIC BASE): FROM 14-APR-2026 - SERIOUS - UNKNOWN #2: DEVICE FRAGMENT EMBEDDED V28.1 (THE NEEDLE REMAINED LODGED IN THE MUCOUS MEMBRANE AND COULD NOT BE REMOVED): FROM (B)(6) 2026 - SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM FRANCE LOCAL REFERENCE: FR-SEPTODONT-(B)(4); ID= (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 14-APR-2026 FROM THE DENTIST BY EMAIL VIA SALES REPRESENTATIVE. THE REPORT DESCRIBED A NEEDLE ISSUE AND EMBEDDED DEVICE WITH THE SUSPECTED MEDICAL DEVICE SEPTOJECT DURING PERIAPICAL INJECTION ON THE VESTIBULAR SIDE OF TOOTH # (B)(6), PRIOR TO AN UNSPECIFIED PROCEDURE. THIS CASE OCCURED ON A 43-YEAR-OLD MALE PATIENT, WITH AN UNSPECIFIED MEDICAL HISTORY. ON (B)(6) 2026, DURING INJECTION, THE NEEDLE BROKE AT THE HUB AND REMAINED LODGED IN THE MUCOSA, UNABLE TO BE REMOVED. THE DENTIST CONTACTED A STOMATOLOGIST, THE LATTER REASSURED THE PRACTITIONER AND TOLD HER THAT THE LOCATION OF THE NEEDLE WAS NOT SERIOUS. OUTCOME: AT THE TIME OF THE REPORT, NO ADVERSE EVENT WAS REPORTED. OTHER INFORMATION OF PRODUCT: SEPTOJECT, BATCH NUMBER # F11915AA, EXPIRY DATE: 31-OCT-2027. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO OTHER MEDICALLY IMPORTANT CONDITION. NO OTHER INFORMATION AVAILABLE. -- *MARKET DISTRIBUTION OF DEVICE: OTHER:S DZ, VN, MY, AU, CL, RU, MD, CR, US, IR, AE, EC, KZ, SG, QA, AR, ID, SA, HK, ZA, MK, JO, TN, MR, MO, AL, MT, HN, PK, CO, GE, BF, OM, LB, UA, SV, TM, BY, TT, AZ, MG, DO, MM, NP, XK, KW, AM, ET, KE, SN, BD, PH, BH, ME, TH, IL. ------- MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE INFORMATION AVAILABLE, THE REPORT DESCRIBED A NEEDLE ISSUE AND EMBEDDED DEVICE WITH THE SUSPECTED MEDICAL DEVICE SEPTOJECT ON A 43-YEAR-OLD MALE PATIENT, WITH AN UNSPECIFIED MEDICAL HISTORY. DURING INJECTION, THE NEEDLE BROKE AT THE HUB AND REMAINED LODGED IN THE MUCOSA, UNABLE TO BE REMOVED. NO ADVERSE EVENT WAS REPORTED. PENDING QUALITY INVESTIGATIONS, NO ROOT CAUSE COULD BE DETERMINED. A QUALITY DEFECT MAY BE SUSPECTED. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, AND IN THE ABSENCE OF ANTERIORITY ON THE BATCH, NO CAPA IS REQUIRED.

Additional Manufacturer Narrative

REPROCESSED: UNK.