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

Model Number	55840007545
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information received from clinical study, healthcare provider via manufacturer representative regarding an event happened during post-op of a patient with clinical patient id (b)(6), study id (b)(6).Event: it was reported that, on (b)(6) 2023 patient reported new left buttock pain that started about 2 months ago, reports that pain is achy and runs down left lower extremity (lle).Site related assessment: possibly related to interbody fusion, posterior fixation and surgical procedure.Not related to plf grafting material and related to surgical construct and/or study procedure.Sponsor assessment: yes description: left buttock pain with radiation.Onset date: (b)(6) 2023, diagnostics: action type: diagnostic action sub-type : l-spine 4 vw-1 action date : (b)(6) 2023, interventions : action subtype : other action result: y- film conference to review/read study ct from (b)(6) 2023.Should avoid bending at back <(>&<)> bend from the knees to avoid back injury, should hold off on activities such as kayaking until radiologist reads ct.Additional information received on 2024-feb-29: action type: diagnostic action subtype: l-spine 4 vw-1 action result: normal action date: 2023-07-31, action type: diagnostic action subtype: study (b)(6) action result: abnormal, action date: 2023, action info: diagnostic tests performed: small amount of lucency on s1 screws.Additional information received on 08-mar-2024: site assessment: possibly related to procedure, plf grafting material, posterior fixation and not related to interbody fusion device.Sponsor assessment: not related to plf grafting material, interbody fusion, surgical procedure and possibly related to posterior fixation.Procedure date: (b)(6) 2022 target levels: l4/l5; l5/s1 additional information received.There was no plan to perform revision surgery to explant the s1 screw.
Additional Manufacturer Narrative
D4: it was unknown whether the lot#h5724022 or lot#h5759696 has the malfunction.Hence, both the lot numbers were reported.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.
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 stating cec assessment as possible related to the procedure, to the posterior lumbar interbody grafting material, to the post fixation and to the interbody device.No further complications reported.
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 that, the outcome status was updated to resolved and the outcome date was (b)(6) 2025.On (b)(6) 2023-patient reported new left buttock pain that started about 2 months ago, reports that pain is achy and runs down left leg extremity.As of (b)(6) 2024- patient was still having pain.Etiology was unknown at this time, (b)(6) 2025- per patient hip pain has resolved.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: 18938979
• Report Number: 1030489-2024-00184
• Device Sequence Number: 7042627
• Product Code: KWP
• UDI-Device Identifier: 00643169004344
• UDI-Public: 00643169004344
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 06/03/2025

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 Model Number: 55840007545
• Device Catalogue Number: 55840007545
• Device Lot Number: H5724022
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 03/24/2025; 05/14/2025
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/15/2025; 06/03/2025
• Date Device Manufactured: 11/12/2021
• 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: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White