KYPHON® HV-R® Bone Cement

Description of Event or Problem

Information was received from healthcare provider (HCP) via a manufacturer representative regarding a cement delivery system used for spinal therapy for pre-operative diagnosis of T9-L3 PPS and T9, L2, L3 FM. It was reported that when a guide was attached to the T9 and the delivery device was set up and filled, leakage from the screw head was confirmed only on the left side. It was filled with 0.8cc, but most of it leaked. After confirming the leakage, the cement at the head portion was removed and the procedure was completed successfully. At the time of guide placement, checks were performed to confirm that the button could not be pressed, that the inner tube could not be withdrawn, and by using a guidewire, but the event still occurred. There were no patient symptoms reported. There were no further complications reported regarding the event. Additional information received that the procedure involved was a posterior thoracolumbar fixation surgery.

Additional Manufacturer Narrative

G4: This product is not marketed in US but a similar device with product number C01A with 510(k)# K041584 and UDI (b)(4) is marketed in US. 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.