MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55740107550
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other - dural repair was performed.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 clinical study, healthcare provider via manufacturer representative regarding a patient with clinical id (b)(4) and study id (b)(6).It was reported that, following decompression, a revision was completed on the left l5 screw due to a medial violation.The screw was removed for repositioning and replacement to a smaller size.Due to the initial medial violation of the first screw, there was a small durotomy on the lateral aspect of the thecal sac within the axial of the l5 nerve root with intact arachnoid space underlying due to the arachnoid space being intact, no leakage of cerebrospinal fluid, and the lateral location primary repair was deemed exceedingly risky.Durotomy was sealed with watertight layer of dura-seal during closure.No cerebrospinal fluid leakage noted.Screw replacement was also checked with x-rays intraoperatively and post operatively.Site seriousness assessment: severity of adverse event was mild.Site related assessment: additional surgery and "other" assessment was not related to capstone peek spinal system implant, tlif grafting material, and procedure.Causal relationship to posterior supplemental fixation system.Sponsor assessment (oc muo): causal related to the procedure and causal related to the posterior supplemental fixation system.Not related to the tlif graft material and to the interbody device.Outcome of this adverse event was recovered/resolved.There were no further complications reported regarding the event.
Event or Problem Description
Additional information received stating the adverse event lumbar durotomy was causally related to the procedure by the site.No further complications reported.
Additional Manufacturer Narrative
Additional information: b5.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.
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
Additional information was received from manufacturer representative stating procedure/technique performed was pedicle screw placement.As an additional procedure, dura-seal was placed over the lateral durotomy following grafting and lift placement (during closure).There was no hospitalization of patient as a result.No further complications reported.
Additional Manufacturer Narrative
Additional information: b5.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
Additional information received from manufacturer representative stating the levels implanted were l3-l4 and l4-l5.No further complications reported.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21135388
• Report Number: 1030489-2025-00189
• Device Sequence Number: 6829617
• Product Code: KWP
• UDI-Device Identifier: 00643169052109
• UDI-Public: 00643169052109
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55740107550
• Device Catalogue Number: 55740107550
• Device Lot Number: H5743593
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 02/14/2025; 03/11/2025; 10/27/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/06/2025; 03/23/2025; 11/18/2025
• Date Device Manufactured: 05/02/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White