inforMED
MalfunctionKIH

KYPHON EXPRESS BONE BIOPSY DEVICE

Received Apr 30, 2025 · Event occurred Apr 21, 2025

Report MW5169673 · MDR key 21936541

Device

Generic name

Dispenser, Cement

Lot number

2303302220

Product problems

  • Break

Patient

55 YR · Male

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

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. NEUROSURGERY 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 OPERATIVE MICROSCOPE TO SUCCESSFULLY REMOVE THE REMAINDER OF THE RETAINED NEEDLE. DURING IR (INTERVENTIONAL RADIOLOGY) AND OR (OPERATING ROOM) PROCEDURES BONE NOTED TO BE SCLEROTIC.