MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. KYPHON XPEDE BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number CX01A

Device Problem Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/03/2019

Event Type  Injury  

Event Description

Kyphon xpede bone cement, cat #cx01a, lot # el70018.Used for kyphoplasty procedure on (b)(6) 2019.Pt emergently returned to hosp on (b)(6).Exploratory laparotomy and exploration of vena cava found 4-5cm foreign body, white hard.On (b)(6), pt taken to operating room for median sternotomy exploration of right ventricle and right pulmonary artery finding a 4-5cm white hard foreign body.Fda safety report id# (b)(4).

• Brand Name: KYPHON XPEDE BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 8888798
• MDR Text Key: 154324186
• Report Number: MW5088978
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: CX01A
• Device Catalogue Number: CX01A
• Device Lot Number: EL70018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR