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

Model Number	25740018560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Device evaluation summary: product analysis #(b)(4):part # 25740018560 lot # ca20f110 visual and optical inspection confirmed the tulip of the bones screw has been splayed/bent from bend stress overload.A: select patient information cannot be included in regulatory report due to regional privacy regulations.G2: the country of the event is japan.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 a healthcare professional(hcp) via a manufacturer representative regarding a spinal device used in sacral fracture.It was reported that when the set screw was tightened to the ballast screw, the set screw entered at an angle, and the final tightening could not be done.It was pointed out that the screw head was broken.The operation was successfully completed by replacing it with another screw.Level at which implant was performed l5/iliac.There were no patient symptoms or complications associated with this event.Hence, no further complications were reported/anticipated.Additional information was received from the manufacturer representative that the product came in contact with the patient.Additional information was received from the manufacturer representative that there was no malfunction with the set screws.

• 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: 21133002
• Report Number: 1030489-2025-00184
• Device Sequence Number: 7516768
• Product Code: NKB
• UDI-Device Identifier: 00643169414891
• UDI-Public: 00643169414891
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2025

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: 25740018560
• Device Catalogue Number: 25740018560
• Device Lot Number: CA20F110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2023
• Initial Report FDA Received Date: 01/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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: Unknown