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

Model Number	CX01A
Medical Device Problem Codes	Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, user facility, distributor) regarding a product used for spinal therapy.It was reported that the outer packaging of the cement was wet upon receipt, and it was suspected that a liquid container may have leaked or broken.There was no patient involved and no further complications or symptoms reported.
Additional Manufacturer Narrative
E: first name and last name of initial reporter is unknown.G2: country of origin is taiwan.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.
Additional Manufacturer Narrative
H3: product analysis of part# cx01a, lot# el70354 visual inspection confirmed the polymer in the vial has leaked in the package and on the package of the cement powder.The vial appears to have been damaged during the shipping process.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: 22640643
• Report Number: 1030489-2025-02520
• Device Sequence Number: 14750897
• Product Code: NDN
• UDI-Device Identifier: 00643169097803
• UDI-Public: (01)00643169097803(17)280131(10)EL70354
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: Other
• Device Model Number: CX01A
• Device Catalogue Number: CX01A
• Device Lot Number: EL70354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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