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

Model Number	JLT-MX 60 16-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Obstruction/Occlusion (2422); Vertebral Fracture (4520)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
We received a complaint from france on 04.Jun.2024 reporting 3 averse events.The patient underwent a surgery on (b)(6) 2022 (cage implantation).First adverse event reported: event start date: (b)(6) 2022.Event description: intervention to stabilize the lumbosacral junction with arthrodesis l4l5s1.L5 factured due to osteoporosis.Cage are not removed.Event stop date: (b)(6) 2022.Second adverse event reported: event start date: (b)(6) 2022.Event description: flank lateral incisional hernia: repair by abdominal wall herniorrhaphy (no implant).Action taken: reintervention on (b)(6) 2022.Event stop date: (b)(6) 2022.Third adverse event reported: event start date: not reported.Event description: undergoing digestive surgery for an occlusion of the grafted intestine, possibly due to a flange or adhesion following the wall surgery he underwent a few months earlier.Action taken: surgery, date unknown.Event stop date: not reported.
Event or Problem Description
We received a complaint from france on 04.Jun.2024 reporting 3 averse events.The patient underwent a surgery on (b)(6) 2022 (cage implantation).First adverse event reported: event start date: (b)(6) 2022.Event description: intervention to stabilize the lumbosacral junction with arthrodesis l4l5s1.L5 fractured due to osteoporosis.Cage are not removed.Event stop date: (b)(6) 2022.Second adverse event reported: event start date: (b)(6) 2022.Event description: flank lateral incisional hernia: repair by abdominal wall herniorrhaphy (no implant).Action taken: reintervention on (b)(6) 2022.Event stop date: (b)(6) 2022.Third adverse event reported: event start date: not reported.Event description: undergoing digestive surgery for an occlusion of the grafted intestine, possibly due to a flange or adhesion following the wall surgery he underwent a few months earlier.Action taken: surgery, date unknown event stop date: not reported.
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.The first event reports an intervention to stabilize the lumbosacral junction with arthrodesis l4-l5-s1.L5 was fractured due to osteoporosis.This event is clearly linked to a severely damaged bone structures that could prevent stable implantation of the cage.This contraindication is clearly mentioned in the ifu.This event is patient related.The second event reports an incisional hernia.Scientific literature reports that ventral hernia is common complication of abdominal surgeries ((b)(4)).Plus, this side effect is clearly identified in the clinical evaluation report (b)(4).Based on the above information, we conclude that the issue reported is not linked to the device implanted but that it is related to the procedure.The third event reports an occlusion (bowel obstruction).As per the investigator, this event is probably due to the previous surgery (wall surgery).Based on the above information, we conclude that the issue reported is not linked to the device implanted but that it is related to the procedure.Based on the above information, the first event reported is due to the patient condition, the second and the third event reported are directly linked to the procedure.We close the case as is with no further action.

• 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: 19612925
• Report Number: 3007728266-2024-00009
• Device Sequence Number: 15029050
• Product Code: OVD
• UDI-Device Identifier: 07640178987166
• UDI-Public: 07640178987166
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 60 16-S
• Device Catalogue Number: JLT-MX 60 16-S
• Device Lot Number: 5-7935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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: 66 YR
• Patient Sex: Male