MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. KYPHON; KYPHOPLASTY CATHETER

Model Number KYPHOPAK EXPRESS II TRAY 1ST FX

Device Problems Material Rupture (1546); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Medtronic left kyphoplasty balloon ruptured after injecting 2ml of cement from right side (left balloon at t6 inflated to 3.0ml at 106psi).

• Brand Name: KYPHON
• Type of Device: KYPHOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; memphis 38132
• MDR Report Key: 4412592
• MDR Text Key: 5275248
• Report Number: MW5040169
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KYPHOPAK EXPRESS II TRAY 1ST FX
• Device Catalogue Number: KPX153PB
• Device Lot Number: 0007366951
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR