MAUDE Adverse Event Report: SPINEART SA LATERAL LUMBAR TI-LIFE CAGE

Model Number	JLT-MX 50 14-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 17.May.2024, we received a complaint from the field (see cpt-2996 folder), from france, reporting that, after a surgery realized on (b)(6) 2022, the patient started to have pain with slight lameness when walking in the right lower limb, truncated in the thigh, rather on the antero-lateral side, since (b)(6) 2022.The action taken at this time were hip x-ray assessment, mri assessment then consultation.On 03.Jun.2024, we received additional information.The patient started to have persistent lumboradicular pain in the right lower limb, typical sciatica, increasingly incapacitating mechanics since 01.Dec.2023.A lumbar mri and infiltration were realized.A discal hernia at adjacent segment l5/s1 was detected.The patient underwent a new intervention on (b)(6) 2024 (lumbar discectomy, no explantation).
Additional Manufacturer Narrative
After we received the complaint, the manufacturing folder has been reviewed.The analysis on the manufacturing documents and control quality documents detected that raw materials and production processes were conforming to the specifications.We received a postoperative picture showing a discal hernia at adjacent segment l5/s1 (mri on (b)(6) 2024).Adjacent segment disease (asd) is a side effect clinically well-known.As per scientific literature, adjacent-segment disease (asd) is a relatively common indication for further surgical intervention after lumbar spine surgery: - "adjacent-segment disease (asd) requiring operative intervention is a relatively common long-term consequence of lumbar fusion surgery" (incidence of adjacent-segment surgery following stand-alone lateral lumbar interbody fusion - jns spine) - adjacent segment degeneration after short-segment lateral lumbar interbody fusion (llif) - pmc (nih.Gov) - national library of medicine - characterization and rate of symptomatic adjacent-segment disease after index lateral lumbar interbody fusion: a single-institution, multisurgeon case series with long-term follow-up in: journal of neurosurgery: spine volume 35 issue 2 (2021) journals (thejns.Org) - jns journal of neurosurgery based on the above information, the event reported is due to the procedure.We close the case as is with no further action.Because of re-intervention surgery (no explantation) we decided to inform (b)(6) via (b)(4) and to inform fda via mdr-10-2024 because the device involved is us marketed.

• Brand Name: LATERAL LUMBAR TI-LIFE CAGE
• Common Device Name: LATERAL LUMBAR TI-LIFE CAGE
• Manufacturer (Section D): SPINEART SA; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 19728087
• Report Number: 3007728266-2024-00010
• Device Sequence Number: 18194642
• Product Code: OVD
• UDI-Device Identifier: 07640178987074
• UDI-Public: (01)07640178987074(17)280107(10)4-9573
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: JLT-MX 50 14-S
• Device Catalogue Number: JLT-MX 50 14-S
• Device Lot Number: 4-9573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female