MAUDE Adverse Event Report: STRYKER CORPORATION IVAS - KIT INTERVENTIONAL SPINE IVAS INFLATABLE VERTEBRAL AUGMENTATION SYSTEM; CEMENT, BONE, VERTEBROPLASTY

Model Number	0705315000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was having kyphoplasty procedure of their l1 vertebra (1st lumbar) where the provider gets access to the vertebral through pedicle using a needle and hammer.After getting access to the vertebral body removing the inner stylet of the needle, but before injecting the cement, the provider will inflate a balloon inside the vertebral body to create more space for the cement.The balloon is inflated with contrast (isovue 300), and while inflating it during this procedure, the balloon popped.The patients chart did not state any allergy to contrast media.However, the patient told us prior to the procedure that she had a ct scan with iv contrast and had a reaction, although she could not remember exactly what her reaction was.This was discussed pre-procedure will all team members involved (provider, nurse, techs), so everyone was aware.The patient did not have any visible reaction during this procedure after the balloon popped.

• Brand Name: IVAS - KIT INTERVENTIONAL SPINE IVAS INFLATABLE VERTEBRAL AUGMENTATION SYSTEM
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 8083858
• Report Number: 8083858
• Device Sequence Number: 16536392
• Product Code: NDN
• UDI-Device Identifier: 07613252505969
• UDI-Public: (01)07613252505969
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018
• Report Date (Section F): 11/12/2018

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 Model Number: 0705315000
• Device Catalogue Number: 0705315000
• Device Lot Number: 18263012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/12/2018