MAUDE Adverse Event Report: Medtronic Sofamor Danek USA, Inc OsteoCool¿2.0 RF Ablation System; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	OC04-100
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from the healthcare professional via a manufacturer representative regarding a device used for balloon kyph oplasty.It was reported that the when the oc probes were connected to the connector hub, the connector hub did not recognize the probes as connected.Never got an error message.Multiple probes were attempted; however, the generator screen continued to display "connect probes." as a result, the ablation could not be initiated.The physician elected to proceed with the bkp and was able to complete the case.No harm to the patient.The generator was unplugged and restarted twice.The probes were exchanged, and each of the four probe connections was tested and didn't worked, the issue was the connector hub and not the generator itself.There was no patient involvement reported.There were no further complications reported regarding the event.Additional information was received as event occurred during pre-op.
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.

• Brand Name: OsteoCool¿2.0 RF Ablation System
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): Medtronic Sofamor Danek USA, Inc; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): Medtronic Sofamor Danek USA, Inc; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; +1(763)526-5677
• MDR Report Key: 50064299
• Report Number: 1030489-2026-00014
• Device Sequence Number: 10121057
• Product Code: GEI
• UDI-Device Identifier: 00763000764043
• UDI-Public: (01)00763000764043(11)240909(10)RB24J001
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K233830
• 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): 07/28/2026

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: OC04-100
• Device Catalogue Number: OC04-100
• Device Lot Number: RB24J001
• 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: 07/13/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 09/09/2024
• 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