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

Model Number	55840007540
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Seroma (2069); Ambulation or Postural Difficulties (2544)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient having spinal therapy.It was reported that, post procedure hardware failure was identified on the anterior column of spine.Acute right lower extremity pain that starts in the ankle and radiates up into leg.Reports difficulty ambulating.Computed tomography performed on 8 july found fracture of superior s1 vertebral body, nondisplaced sacral alar fracture involving left s1 screw, periprosthetic lucency surrounding right s1 screw could relate to loosening, anterolisthesis of l5 on s1 ~ 8mm.Nonspecific fluid within the posterior paraspinal soft tissues.Reported adverse event was possibly related to study procedure (index surgery) possibly related to study device.Adverse event resulted in usage of concomitant medication.Additional surgery.Patient was hospitalized from (b)(6) 2024.Additionally, physical therapy and diagnostic tests were performed.Additional surgery was performed was (b)(6) 2024.Outcome of adverse event was recovering/resolving.Additionally doppler diagnostic test was performed on (b)(6) 2024.Duplex test results show negative right lower extremity.No further complications reported.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 55840008580, serial/lot #: unknown, udi# (b)(4).Product id: 55840008540, serial/lot #: unknown, udi# (b)(4).It was unclear which of the reported screws in the event were malfunctioned, hence mdr has been submitted for all the reported screws.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 received.The adverse event end date was 16/jul/2024.

• 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: 20074276
• Report Number: 1030489-2024-01050
• Device Sequence Number: 12389006
• Product Code: KWP
• UDI-Device Identifier: 00643169004337
• UDI-Public: 00643169004337
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 55840007540
• Device Catalogue Number: 55840007540
• Device Lot Number: UNKNOWN
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11.".
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG