MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC Kyphon V 13ga KIT with Kyphon CDS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPK013D
Medical Device Problem Codes	Positioning Failure (1158); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
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 the healthcare professional via a manufacturer representative regarding a device used for spinal therapy.L3 level was implanted and fracture was the pre-operative diagnosis for this procedure and there was a delay in overall procedure time.It was reported that the physician was trying to redirect the trocar and it wasn't following the direction of the arrow on top of the stylet.He removed the stylet and noticed it was pointing in the opposite direction.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information was received as procedure was delayed about 2-3 minutes.

• Brand Name: Kyphon V 13ga KIT with Kyphon CDS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea road; memphis,tn
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea road; memphis,tn
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; +1(763)526-5677
• MDR Report Key: 50927527
• Report Number: 3003120897-2026-01639
• Device Sequence Number: 21522435
• Product Code: LXH
• UDI-Device Identifier: 00643169637498
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/28/2026

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: VPK013D
• Device Catalogue Number: VPK013D
• Device Lot Number: 0234476557
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 08/24/2026
• 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: Male