KYPHON® EXPRESS¿ BONE BIOPSY DEVICE

Description of Event or Problem

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.

Description of Event or Problem

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.