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

Model Number	25100401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: part # 25100401, lot # ct18m016.Visual inspection revealed the entire torx tip has broken.Optical examination of the fracture surface revealed a fairly flat fracture surface with circular material flow.The damage to the driver is consistent with overload.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 the health care professional via a manufacturer representative regarding a device used for spinal fusion therapy.It was reported that the instruments were broken and the enamel within the tray was flaking and causing contamination concerns.There were no patient symptoms reported.There were no further complications reported regarding the event.Events occurred on the back table.Inserter would no longer clamp down on a rod to secure the rod for insertion and the probe's tip was damaged / chipped.Nothing physically broke off.Threads were damage and wouldn't attach to a trial and tip of the driver snapped off while attempting to attach a screw to the driver and all instruments were previously used without issue.

• Brand Name: CD HORIZON® BALLAST¿ SPINAL SYSTEM
• Common Device Name: SCREWDRIVER
• 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: 24673273
• Report Number: 3003120897-2026-00573
• Device Sequence Number: 18679283
• Product Code: HXX
• UDI-Device Identifier: 00643169623996
• UDI-Public: (01)00643169623996(11)190115(10)CT18M016
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/24/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown