MAUDE Adverse Event Report: STRYKER MEDICAL/STRYKER INSTRUMENTS VERTAPLEXHV RADIOPAQUE BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number 0607-687-000

Patient Problem Paralysis (1997)

Event Date 11/22/2023

Event Type  Injury  

Event Description

Vertaplex hp bone cement was used during a t12 spine jack w/kyphoplasty.Cement appropriately filled the vertebral body and the implant under fluoroscopic visualization.The view was switched to ap view to look for continuity of cement across the midline and it was noticed that there was cement extravasation from the vertebral body of t12 in a cephalad direction up to t10.Implants were immediately deployed, incisions closed, and the pt was turned supine.The pt was awakened and able to move their arms and follow commands but was unable to move their lower extremities.The surgeon has used this product multiple times, verified the appropriate amount was used during the procedure, and stated they have never seen the bone cement extravagate like this.Reference report: (b)(4).

• Brand Name: VERTAPLEXHV RADIOPAQUE BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER MEDICAL/STRYKER INSTRUMENTS
• MDR Report Key: 18443552
• MDR Text Key: 332143332
• Report Number: MW5149753
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0607-687-000
• Device Lot Number: VCE019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White