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

Model Number	55840007550
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding an event which occurred post a clinical study (study id: (b)(6) spinal fusion procedure in a patient (patient id: (b)(6).Patient history: primary diagnostic indication: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis) from l2 ¿ s1 at 3 levels.Substance use: alcohol and tobacco.It was reported that nuc 3 phase limited bone scan was performed on (b)(6) 2025, spect-ct showed increased uptake along the right l2 screw.Similar postsurgical changes in the lumbar spine including posterior fixation from l2 through l5.Per treating physician note, spect ct which show some uptake around right l2 screw, which could be some potential loosening.He is going to continue his physical therapy in the meantime.As per site related assessment, it is not likely that event is related to posterior fixation and is related to surgical construct and/or study procedure.As per sponsor assessment, event is causally related to posterior fixation and not related to the procedure, plf graft and interbody device.Additional surgery was performed on (b)(6)2023 for right partial glossectomy and floor of mouth resection with primary closure.Additional surgery is not related to surgical construct or study procedure. there was no patient symptom reported.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.
Additional Manufacturer Narrative
B5: event 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.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 procedure date: (b)(6) 2025 c2-5 posterior cervical fusion with c3/4 laminectomy additional procedure is not related to surgical construct and/or the study procedure.

• 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: 22410373
• Report Number: 1030489-2025-02398
• Device Sequence Number: 8352852
• Product Code: KWP
• UDI-Device Identifier: 00643169004351
• UDI-Public: 00643169004351
• 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: 2022
• 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): 09/04/2025

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 Expiration Date: 09/01/2023
• Device Model Number: 55840007550
• Device Catalogue Number: 55840007550
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 12/08/2021
• 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 Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White