MAUDE Adverse Event Report: STRYKER PUERTO RICO, LLC. VERTEBRAPLASTY TRAY IVAS ELITE BALLOON SYSTEM; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number 0306-330-000

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/18/2021

Event Type  Injury  

Event Description

Spiral fracture of 11g ivas cannula caused retained foreign object and extrusion of cement; required surgical intervention to retrieve and add'l fluoroscopy time to the patient.By physician: "i placed a jamshidi needle back in there and then began to try to remove it and it was stuck.I could see that the sheared off fragments from the catheter were engaged in the bone.There are also several small pieces of cement that had leaked into the dorsal thoracic musculature.There is no evidence of any cement leakage anywhere near the canal of the nerve roots.I made a slightly larger incision and an operating room team was brought down as they had better equipment.We redraped and gave more local anesthetic.We made a slightly large incision around the jamshidi needle on the right side and opened up the thoracic fascia, a little bit over the muscles.I followed this down to where the jamshidi needle into the pedicle at the facet joint.Some blocks of cement that were exited from the cracks in the jamshidi needle cannula into the dorsal musculature were removed.I could see from the x-rays there were no further retained bodies.I then used a straight curette to dissect around the top of the jamshidi needle.Using ap imaging, i placed the tip of the straight curette right on top of the jamshidi needle at the lateral border of the pedicle and then carefully tapped this down on top of the jamshidi needle under biplanar fluoroscopy into the vertebral body.Again, as with the needles, care was taken to make sure the medial border of the pedicle was not violated in the ap view prior to entering the body of the vertebra on the lateral view.We then took some large locking vice grips and i was able to get these down through the skin incision and put the tips of them right on the base of the jamshidi needle with the cannula in it at the dorsal aspect of the facet joint.With a pull and a twist everything came out at that point in time.There was no evidence of any retained fragments.I inspected the cannula and could see that there was a spiral fracture running through the posterior two-thirds of the surface of the cannula.This was the problem that the sheared cannula was catching up on the bone as i tried to pull it out before.Multiple x-rays taken to make sure there were no further retained foreign bodies and none were seen.Local anesthetic was injected.Irrigation was performed, and then closure was done anatomically in layers with a few sutures into the dorsal fascia, some in the subcutaneous tissue as well." fda safety report id# (b)(4).

• Brand Name: VERTEBRAPLASTY TRAY IVAS ELITE BALLOON SYSTEM
• Type of Device: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER PUERTO RICO, LLC.
• MDR Report Key: 12377293
• MDR Text Key: 269415589
• Report Number: MW5103536
• Device Sequence Number: 1
• Product Code: OAR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/24/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0306-330-000
• Device Lot Number: 21007012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 84 YR