Description of Event or Problem · 0
WE RECEIVED ON 02 APR 2025 A COMPLAINT ((B)(4)) FROM SWITZERLAND REPORTING THE FOLLOWING EVENT: THE PATIENT RECEIVED 2 JULIET TI CAGES AT 2 LEVELS: JUT-T6 34 09-S, BATCH N° 7-2150 AT LEVEL L4-L5, JUT-T6 34 11-S, BATCH N° 6-8618 AT LEVEL L5-S1. THE PATIENT ALSO RECEIVED OTHER MATERIAL FROM ANOTHER BRAND: 2 PEDICLE SCREWS AND 2 NUTS + 1 ROD AT LEVEL L4, 2 PEDICLE SCREWS AND 2 NUTS + 1 ROD AT LEVEL L5, 2 PEDICLE SCREWS AND 2 NUTS + 1 ROD AT LEVEL S1, BONE SUBSTITUTE AT LEVEL L4. 1. THE PATIENT HAD AN INITIAL SURGERY ON (B)(6) 2023. 2. EVENT START DATE: JUNE 2024. THE PATIENT WENT TO ANOTHER SURGEON FOR REVISION SURGERY WITHOUT INFORMING DR (B)(6). 3. REINTERVENTION DATE: (B)(6) 2024. THE SURGERY REPORT FROM THE OTHER SURGEON DESCRIBES: A PSEUDOARTHROSIS AT LEVEL L4-L5, A REDUCED LUMBAR CANAL AT LEVEL L3-L4 (NEW), A RECURRING REDUCED LUMBAR CANAL AT LEVELS L4-L5, L5-S1. DURING THE REINTERVENTION SURGERY, THE PATIENT UNDERWENT: A DECOMPRESSION AT LEVELS L3-S1 (3 LEVELS), EXTENSION OF SPONDYLODESIS UP TO L3 (PREVIOUSLY IT WAS ONLY L4-S1), CHANGE OF SCREWS (NON-SPINEART) AT LEVELS L4-S1. 4. EVENT END DATE: 04 JULY 2024 NOTE THAT THE PATIENT WAS LOST TO FOLLOW-UP AFTER HIS 6M VISIT. THIS REVISION SURGERY TOOK PLACE BETWEEN THE 6M AND 12M VISIT. AT HIS 6M VISIT, THE PATIENT WAS DOING FINE WITH A LITTLE BIT OF PAIN (VAS = 3) BUT NOT DISABLING.