MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	6068093
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other- vertebral body fracture h6 - neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient having clinical id (b)(6).It was reported that ct postop showed vertebral body fracture interventions action subtype: ae result in hospitalization action result: n if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: any other action(s) taken action result: y other action taken: l50 rigid brace action subtype: did the ae result in any treatment action result: n diagnostics action type: diagnostic action subtype: ct without contrast1 action result: lumbar fracture action date: (b)(6) 2023 action type: diagnostic action subtype: were any diagnostic test performed action result: y site related assessment: causal relationship to posterior supplemental fixation system and not related to tlif grafting material, procedure and capstone peek spinal system implant.(b)(6) 2024, update received action subtype: ae result in hospitalization action result: y action date: (b)(6) 2023 end date of the hospitalization: (b)(6) 2023 if subject hospitalized, is it a prolongation (>24hours) of an existing hospitalization: y narrative: ct postop showed vertebral body fracture near screw.Patient had increased pain and an extended hospital stay.No intervention was needed.Site related assessment: study procedure- causal relationship onset date: (b)(6) 2023 description: l4-l5 vertebral body fracture outcome status: recovering/resolving site related assessment: causal relationship to posterior supplemental fixation system and l4-5 tlif procedure and not related to tlif grafting material, capstone peek spinal system implant.Sponsor assessment: possible to tlif procedure, tlif grafting material, and body fusion device.Causal to posterior supplemental fixation system.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient having clinical id (b)(6).It was reported that ct postop showed vertebral body fracture interventions action subtype: ae result in hospitalization action result: n if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: any other action(s) taken action result: y other action taken: l50 rigid brace action subtype: did the ae result in any treatment action result: n diagnostics action type: diagnostic action subtype: ct without contrast1 action result: lumbar fracture action date: (b)(6) 2023 action type: diagnostic action subtype: were any diagnostic test performed action result: y site related assessment: causal relationship to posterior supplemental fixation system and not related to tlif grafting material, procedure and capstone peek spinal system implant.On (b)(6) 2024, update received action subtype: ae result in hospitalization action result: y action date: on (b)(6)2023 end date of the hospitalization: on (b)(6) 2023 if subject hospitalized, is it a prolongation (>24hours) of an existing hospitalization: y narrative: ct postop showed vertebral body fracture near screw.Patient had increased pain and an extended hospital stay.No intervention was needed.Site related assessment: study procedure- causal relationship onset date: 2023-12-07 description: l4-l5 vertebral body fracture outcome status: recovering/resolving site related assessment: causal relationship to posterior supplemental fixation system and l4-5 tlif procedure and not related to tlif grafting material, capstone peek spinal system implant.Sponsor assessment: possible to tlif procedure, tlif grafting material, and body fusion device.Causal to posterior supplemental fixation system.On (b)(6) 2024, update received the sponsor and cec assessment determined the event as causal to the tlif procedure, not related to the tlif grafting material, possibly related to the body fusion device, and causal to the posterior supplemental fixation system.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient having clinical id (b)(6).It was reported that ct postop showed vertebral body fracture interventions action subtype: ae result in hospitalization action result: n if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: any other action(s) taken action result: y other action taken: l50 rigid brace action subtype: did the ae result in any treatment action result: n diagnostics action type: diagnostic action subtype: ct without contrast1 action result: lumbar fracture action date: on (b)(6) 2023 action type: diagnostic action subtype: were any diagnostic test performed action result: y site related assessment: causal relationship to posterior supplemental fixation system and not related to tlif grafting material, procedure and capstone peek spinal system implant.2024-03-30, update received action subtype: ae result in hospitalization action result: y action date: on (b)(6) 2023 end date of the hospitalization: on (b)(6) 2023 if subject hospitalized, is it a prolongation (>24hours) of an existing hospitalization: y narrative: ct postop showed vertebral body fracture near screw.Patient had increased pain and an extended hospital stay.No intervention was needed.Site related assessment: study procedure- causal relationship onset date: 2023-12-07 description: l4-l5 vertebral body fracture outcome status: recovering/resolving site related assessment: causal relationship to posterior supplemental fixation system and l4-5 tlif procedure and not related to tlif grafting material, capstone peek spinal system implant.Sponsor assessment: possible to tlif procedure, tlif grafting material, and body fusion device.Causal to posterior supplemental fixation system.On (b)(6) 2024, update received the sponsor and cec assessment determined the event as causal to the tlif procedure, not related to the tlif grafting material, possibly related to the body fusion device, and causal to the posterior supplemental fixation system.On (b)(6) 2024, update received site related assessment: capstone peek spinal system implant - possible.
Additional Manufacturer Narrative
B5.Desc evt problem updated medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient having clinical id (b)(6).It was reported that ct postop showed vertebral body fracture interventions action subtype: ae result in hospitalization action result: n if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: any other action(s) taken action result: y other action taken: l50 rigid brace action subtype: did the ae result in any treatment action result: n diagnostics action type: diagnostic action subtype: ct without contrast1 action result: lumbar fracture action date: (b)(6)2023 action type: diagnostic action subtype: were any diagnostic test performed action result: y site related assessment: causal relationship to posterior supplemental fixation system and not related to tlif grafting material, procedure and capstone peek spinal system implant.(b)(6)2024, update received action subtype: ae result in hospitalization action result: y action date: (b)(6)2023 end date of the hospitalization: (b)(6)2023 if subject hospitalized, is it a prolongation (>24hours) of an existing hospitalization: y narrative: ct postop showed vertebral body fracture near screw.Patient had increased pain and an extended hospital stay.No intervention was needed.Site related assessment: study procedure- causal relationship onset date: (b)(6)2023 description: l4-l5 vertebral body fracture outcome status: recovering/resolving site related assessment: causal relationship to posterior supplemental fixation system and l4-5 tlif procedure and not related to tlif grafting material, capstone peek spinal system implant.Sponsor assessment: possible to tlif procedure, tlif grafting material, and body fusion device.Causal to posterior supplemental fixation system.(b)(6)2024, update received the sponsor and cec assessment determined the event as causal to the tlif procedure, not related to the tlif grafting material, possibly related to the body fusion device, and causal to the posterior supplemental fixation system.(b)(6)2024, update received site related assessment: capstone peek spinal system implant - possible (b)(6)2025, update received action subtype: did the ae result in any treatment action result: y action subtype: any other action(s) taken action result: y other action taken: lso rigid brace site related assessment: reported ae is not related to l4-5 tlif procedure (b)(6)2025, update received update received: site related assessment : causal relationship to procedure (b)(6)2025, update received procedure: lumbar spondylolisthesis : causal relationship to procedure.
Additional Manufacturer Narrative
B5: desc evt problem updated d3: mfr details updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr IN 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr IN 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 19058293
• Report Number: 1030489-2024-00250
• Device Sequence Number: 17609988
• Product Code: MAX
• UDI-Device Identifier: 00763000246723
• UDI-Public: 00763000246723
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/30/2026

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: Health Professional
• Device Model Number: 6068093
• Device Catalogue Number: 6068093
• Device Lot Number: 0922965W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 10/24/2024; 01/29/2025; 06/04/2026
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 10/18/2024; 10/28/2024; 02/25/2025; 06/30/2026
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American