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

Model Number	55840006545
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	02/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of part # 55840006545 ; lot # h5915695 visual and optical inspection confirmed bone screw was returned locked in an angled position.There is wear in the saddle of the bone screw due to the seating and tightening of the rod.The rod appears to have been seated correctly.There is no damage to the screw threads of outer head.The screw appears to function as intended.No fault found.This regulatory report is being submitted due to retrospective review through capa 624392.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 l2 fracture.It was reported that, patient lost motor functions upon torquing off the screws.As a result, the screws were pulled out.Surgeon believes the cocr strength and tightness aspect of the rod contributed to the locking of the screw heads.During the final torquing of the screws that it felt abnormally tight.Surgeon believes the rod was the cause of the issue due to the tightness after torquing off.The procedure was successful.After the loss of motor function, surgeon removed the set screws, rods, and a couple screws and then further decompressed the spine.Procedure or technique performed was posterior thoracolumbar spinal fusion.No additional treatment or surgery performed as a result.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: 21556633
• Report Number: 1030489-2025-01259
• Device Sequence Number: 9127348
• Product Code: KWP
• UDI-Device Identifier: 00613994971753
• UDI-Public: 00613994971753
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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: 55840006545
• Device Catalogue Number: 55840006545
• Device Lot Number: H5915695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2024
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 109 KG