MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® BALLAST¿ SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	25740011090
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: product # 25740011090 lot# ca19l105 after visual and optical examination, it appears that the torx of the screw has been stripped/damaged.This is consistent with overload.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 unknown indication.It was reported that the screws were cold welded/stripped due to driver malfunction intraoperatively.Had to helicopter out after numerous attempts to remove using a multitude of drivers.One of the driver was severely warped after attempting to place 10.5 screw.When attempting to place second screw (10.5x80) the torx tip of the driver snapped off and lodged inside the tulip/torx interface of the screw.Fragments could not be removed and it was left in the pt.The other driver was severely warped after attempting to place 9.5 screw.Surgeon was fearful of snapping off tip of the driver again so the decision was made to helicopter the screw out and leave unilateral pelvic fixation.Products will be returned.There were no patient symptoms or complications reported as a result of this event.Additional information received from manufacturer representative that the procedure involved was psf l2-pelvis with tlif l3-5.Pre-op diagnosis m43.16/m54.16/m40.30/m47.26.Both ballast drivers were severely warped and stripped.The product was used in surgery on the patient.

• Brand Name: CD HORIZON® BALLAST¿ SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21456265
• Report Number: 1030489-2025-00984
• Device Sequence Number: 7937260
• Product Code: NKB
• UDI-Device Identifier: 00643169415126
• UDI-Public: 00643169415126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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: 25740011090
• Device Catalogue Number: 25740011090
• Device Lot Number: CA19L105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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: 59 YR
• Patient Sex: Unknown