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

Model Number	CX01B
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.Pre-op diagnosis of patient was compression fracture.It was reported that the cement delivery system (cds) malfunctioned, as the cement did not advance into the body despite repeated attempts.It was kept pumping the handle of the gun but there was no advancement of the cement and noticed that saline was dripping and then the bag exploded inside the gun and water went everywhere.This necessitated the replacement of the gun.Additionally, the cement was described as too viscous, not doughy or homogenous prior to delivery, and subsequently hardened too quickly, causing further procedural delays.A new batch of cement was mixed, but it also hardened immediately, requiring another batch to be prepared.Procedure/technique performed was kyphoplasty.The procedure was ultimately completed successfully using a new product.The level planned to treat was t12.No patient complications have been reported as a result of this event.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: product analysis of part # cx01b ; lot # 0012536389 visual inspection confirmed the cement in the mixer has dried up.Most of the cement has been dispersed in the cartridges.Unable to determine viscosity of cement at the time of use.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: 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: 21330825
• Report Number: 1030489-2025-00625
• Device Sequence Number: 8620861
• Product Code: NDN
• UDI-Device Identifier: 00643169097797
• UDI-Public: 00643169097797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: CX01B
• Device Catalogue Number: CX01B
• Device Lot Number: 0012536389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/19/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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: Female