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

Model Number	75445535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic image review: the image is a lateral view of the lumbar spine and shows pedicle screws in l5 and s1.One of the s1 screws is broken at the level of the pedicle.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 healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for pre-op diagnosis of lumbar region spondylolisthesis.It was reported that, the screw was broken and the broken implant was inside the patient.As a result, patient had pain in the lower back.Procedure or technique performed was fixation and the reported screw implanted at s1 level was broken.Initial surgery was performed on (b)(6) 2024.Meanwhile during follow-up x-ray, that is on (b)(6) the screw was found broken.No information available on the plan of revision surgery to retrieve the broken screw from patient.There were no further complications reported regarding the event.
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 received from manufacturer representative stating the pre-op diagnosis of patient was chronic pain in right knee for 6-7 months.History of trauma following which child started having pain along the right thigh & knee region which is mild to moderate associated with tingling and numbness intermittently.Pain increases on walking & standing.Mild back pain i intermittent.No history of walking difficulty.Patient took multiple physiotherapy session with partial improvement.On (b)(6) 2023, x-ray lumbar spine was performed and found anterolisthesis of l5 over s1.Magnetic resonance imaging of lumbo-sacral spine with whole spine screening performed on (b)(6) 2023.Grade ii anterolisthesis of l5 over s1 bilateral spondylolysis.Post bro ad based disc bulge at l4-l5 level indicating anterior thecal sac and abutting bilateral existing nerve roots.Post broad based pseudo disc bulge at l5-syndicating anterior thecal sac, narrowing bilateral neural foramina & abutting bilateral existing nerve roots.
Additional Manufacturer Narrative
Additional information: b6.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.

• 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: 19079484
• Report Number: 1030489-2024-00255
• Device Sequence Number: 12229981
• Product Code: KWP
• UDI-Device Identifier: 00885074134000
• UDI-Public: (01)00885074134000(11)230427(10)H5854687
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75445535
• Device Catalogue Number: 75445535
• Device Lot Number: H5854687
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 03/13/2025; 12/15/2025
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/07/2025; 01/08/2026
• Date Device Manufactured: 04/27/2023
• 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
• Patient Age: 11 YR
• Patient Sex: Female