MAUDE Adverse Event Report: STRYKER PUERTO RICO, LLC. AVAFLEX VERTEBRAL BALLOON SYSTEM KYPHOPLASTY BALLOON; ARTHROSCOPE

Model Number 1031-120-000

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

During a kyphoplasty a balloon is used to expand the vertebrae before injecting cement, this particular balloon ruptured.However, came out of pt intact.

• Brand Name: AVAFLEX VERTEBRAL BALLOON SYSTEM KYPHOPLASTY BALLOON
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER PUERTO RICO, LLC.
• MDR Report Key: 12016435
• MDR Text Key: 257410455
• Report Number: MW5101933
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1031-120-000
• Device Lot Number: 6428280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR