KYPHO 1-STEP KIT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-17 for KYPHO 1-STEP KIT * manufactured by Medtronic Spine Llc.

Event Text Entries

[2475212] The l1 and l2 pedicles were cannulated. This was done under ap (anterior-posterior) and lateral fluoroscopic guidance. A drill was used and the balloons were advanced, 1 on each side and 2 on each vertebra. They were inflated and the cement was mixed. All the balloons were able to be deflated except for one on the right side, which required some vigorous suction before it was able to be deflated and pulled out. Two reprocessed and two new pieces were opened. It is unknown which product failed to deflate. Serial number sent to manufacturer without retaining the information.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2471929
• MDR Report Key: 2471929
• Date Received: 2012-02-17
• Date of Report: 2012-02-17
• Date of Event: 2012-01-27
• Report Date: 2012-02-17
• Date Reported to FDA: 2012-02-17
• Date Added to Maude: 2012-02-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KYPHO 1-STEP KIT
• Generic Name: INFLATABLE BONE TAMP
• Product Code: HXG
• Date Received: 2012-02-17
• Returned To Mfg: 2012-01-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC SPINE LLC
• Manufacturer Address: 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-02-17