MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV KYPHON® EXPRESS¿ BONE BIOPSY DEVICE; DEVICE, PERCUTANEOUS, BIOPSY

Model Number	F07A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a kyphon express bone biopsy dev ice used for lumbar 4 bone biopsy in interventional radiology.It was reported that patient undergoing lumbar 4 bone biopsy utilizing medtronic kyphon express bone biopsy device (size 2) in interventional radiology.During removal, inner biopsy needle (13-gauge jamshidi needle) broke off inside of patient's l4 region.Multiple attempts to retrieve retained needle fragment were unsuccessful.Ne urosurgery contacted and patient taken to or (operating room) for surgical removal of retained needle.During or procedure, needle continued to crush and fracture when attempting to remove.Initial incision was widened, and microsurgical technique utilizing the op erative microscope to successfully remove the remainder of the retained needle.During ir (interventional radiology) and or (operating room) procedures bone noted to be sclerotic.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
D4 & g4: product identifiers are unknown 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
H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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
Additional information was received from the manufacturer representative that the procedure involved was a core needle biopsy to address discitis at the lumbar 4 vertebrae.There were no patient complications as a result of this event, and the patient experienced no harm, recovered well.The product return status was confirmed as discarded.

• Brand Name: KYPHON® EXPRESS¿ BONE BIOPSY DEVICE
• Common Device Name: DEVICE, PERCUTANEOUS, BIOPSY
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc TN 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc TN 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22153373
• Report Number: 1030489-2025-02139
• Device Sequence Number: 9199797
• Product Code: MJG
• UDI-Device Identifier: 00763000311704
• UDI-Public: (01)00763000311704(17)261216(10)230330220
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F07A
• Device Catalogue Number: F07A
• Device Lot Number: 230330220
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 12/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Unknown