MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® FENESTRATED SCREW SET; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	55840027545T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 received from healthcare provider via manufacturer representative regarding a patient with clinical id (b)(6), study id (b)(6) and sub-event number: 5.Description: pseudoarthrosis w/ halo around s1 screws long description: pseudoarthrosis w/ halo around s1 screws onset date: 2022-07-25.Outcome status: pending interventions: action subtype: other action result: yes- observation only action subtype: other relevant actions action result: yes, site seriousness assessment: there is no congenital anomaly, death, disability, hospitalization, life threatening and medical intervention, but the severity of adverse event is moderate.Site related assessment: not related to interbody fusion, plf grafting material, posterior fixation, surgical construct and/or study procedure or surgical procedure.Diagnostics: action type: diagnostic action subtype: l-spine images-1 action result: abnormal action date: (b)(6) 2022 action info: diagnostic tests performed: pseudoarthrosis w/ halo around s1 screws action type: diagnostic action subtype: l-spine images-2 action result: abnormal action date: (b)(6) 2022 action info: diagnostic tests performed: unchanged since images on (b)(6) 2022 randomization date: (b)(6) 2021 number of levels to be treated: 2 levels pregnant since last visit 6_weeks: has the subject become pregnant since last visit: na date of visit: (b)(6) 2021 pregnant since last visit 3_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2021 pregnant since last visit 6_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2022 pregnant since last visit 12_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2022 pregnant since study surgery unscheduled 1: has the subject become pregnant since the study surgery: na date of visit: (b)(6) 2022 procedure date: (b)(6) 2021 procedure details: treatment group: group 1 - infuse 4.2 + mastergraft + local bone additional surgery date: (b)(6) 2021 additional surgery details: adverse event document number(s) associated with additional surgery: document number: (b)(4) subevent number: 1 describe the additional surgical procedure: wound exploration surgery-wound revision, irrigation, debridement and closure of wound.Index surgery was (b)(6) 2021.Patient was discharged to home on (b)(6) 2021.Levels involved in additional surgical procedure: non-target/non-lumbar level specify the relatedness of the additional surgical procedure to surgical construct and/or the study procedure: related plf grafting material, surgical construct and/or surgical procedure: possible posterior fixation related to surgical construct and/or surgical procedure: unlikely interbody fusion related to surgical construct and/or surgical procedure: unlikely surgical procedure related to surgical construct and/or surgical procedure: possible event: it was reported that the patient seen in clinic for routine 1yr post-op visit with imaging.Imaging revealed pseudoarthrosis with halo around s1 screws.Not symptomatic at this time.At this time; observation only for now.In 6months on (b)(6) 2022 imaging was done and unchanged from last images.Additional information was received that adverse event info: if onset is date of initial treatment procedure, specify time frame: post procedure pregnant since last visit 12_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2023 site related assessment: probable related to interbody fusion and posterior fixation.Related to study procedure.Unlikely related to plf grafting material and surgical procedure.Sponsor assessment (oc muo): possible related to the posterior fixation system and interbody fusion.It is not related to the plf grafting material and procedure.Sponsor assessment (oc muo): cec assessed as causal related to the posterior fixation system and procedure.Possible related to interbody fusion and plf grafting material.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 22260533
• Report Number: 1030489-2025-02253
• Device Sequence Number: 20840988
• Product Code: MNI
• UDI-Device Identifier: 00643169678941
• UDI-Public: 00643169678941
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 55840027545T
• Device Catalogue Number: 55840027545T
• Device Lot Number: H5674430
• 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: 04/21/2023
• Initial Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 03/27/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White