MAUDE Adverse Event Report: CAREFUSION AVAFLEX VERTEBRAL BALLOON SYSTEM/NEEDLE; ARTHROSCOPE

Catalog Number	AFB1020
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt was having a kyphoplasty procedure level t-12 was being done when the needle got stuck and broke off.The dr was able to get the needle out after making a larger incision.Made a larger incision and was able to retrieve it.

• Brand Name: AVAFLEX VERTEBRAL BALLOON SYSTEM/NEEDLE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): CAREFUSION; veron hills IL 60061
• MDR Report Key: 7681162
• Report Number: MW5078324
• Device Sequence Number: 11091834
• Product Code: HRX
• UDI-Device Identifier: 10885403223242
• UDI-Public: 10885403223242
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: AFB1020
• Device Lot Number: 0001111626
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR