MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON® XPEDE¿ BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number	CX01B
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
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 patient having anterior scolio sis correction (asc) spinal therapy for vertebral compression fracture (vcf) at t12.It was reported that there is difficulty getting mixing agitator to fit inside mixer and had difficulty mixing.15-20 seconds passed before started mixing due to difficulties.There was difficulty pushing cement into bone fillers fast enough.There were no further complications or symptoms reported regarding the event.

• Brand Name: KYPHON® XPEDE¿ BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• 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: 20074278
• Report Number: 1030489-2024-01051
• Device Sequence Number: 12389008
• Product Code: NDN
• UDI-Device Identifier: 00643169097797
• UDI-Public: 00643169097797
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K102397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: CX01B
• Device Catalogue Number: CX01B
• Device Lot Number: 0012352046
• 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: 07/29/2024
• Initial Report FDA Received Date: 08/27/2024
• Date Device Manufactured: 07/10/2024
• 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