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

Model Number	25100401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
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
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a driver used on patient having spinal therapy for osteopenia.It was reported that during the placement of ballast screws using the powerease driver in an s2ai trajectory, a patient underwent a procedure in which the surgeon was unable to fully drive the screw due to the insertional torque required.The use of a torque multiplier resulted in the tip of the driver breaking off and becoming lodged in the ballast screw head.The broken off tip was removed by surgeon during the surgery.The screw placement was right above the sciatic notch and down the middle of the "tear drop" view.After the first driver broke, a second driver was used in an attempt to back the screw out, but this driver became stripped.These drivers were new drivers.There were no patient symptoms reported.There were no further complications reported regarding the event.

• 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: 23004741
• Report Number: 3003120897-2025-00205
• Device Sequence Number: 18768887
• Product Code: NKB
• UDI-Device Identifier: 00643169623996
• UDI-Public: (01)00643169623996(11)190115(10)CT18M016
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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: 25100401
• Device Catalogue Number: 25100401
• Device Lot Number: CT18M016
• 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: 08/20/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 01/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male