MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number KY_UNK_PLASTY

Device Problem Failure to Eject (4010)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/19/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Chalhoub g, cheung b, gonzalez c "balloon kyphoplasty complication: a case of a lodged balloon within the vertebral body." cureus 12(9): e10542.(september 19, 2020).Doi 10.7759/cureus.10542 summary: balloon kyphoplasty (bkp) is a minimally invasive, percutaneous procedure used to restore vertebral body height and repair spinal compression fractures caused by osteoporosis.Bkp is indicated for acute symptomatic compression fractures with height loss of >20%.It is a type of vertebroplasty utilizing an inflatable bone tamp in the vertebral body to restore vertebral height prior to injection of bone cement.Similar to traditional vertebroplasty, bkp presents with many complications.Those complications include cement extravasation, thermal injury and post-procedural pain.However, bkp has been shown to be more effective at restoring vertebral height at lower pressures and with fewer complications than traditional vertebroplasty.Bkp has some complications specific to it, such as further vertebral fracture from balloon expansion, balloon rupture, and re-collapse following balloon deflation.This report describes a bkp in which the bone tamp broke off inside the patient and was unable to be removed, the first case of which to be described in the literature.Reported event: this report describes a case involving a balloon kyphoplasty bone tamp becoming lodged inside the vertebral body and unable to be withdrawn, the first report of its kind in the literature.A board certified interventional pain management physician was performing a balloon kyphoplasty for an l3 osteoporotic vertebral compression fracture using a bipedicular approach with two bone tamps.Cannulation and cavity formation were completed without complication; however, upon removal of the balloons it was noted that one had become lodged in the vertebral body.Several attempts were made to remove the balloon.Neurosurgery and the balloon manufacturer were consulted intraoperative, and it was decided to leave the balloon fragments in situ and complete the interventional fixation of the vertebral body with bone cement.The patient followed up in the clinic several months later without neurologic complications.Postoperative radiography confirmed the presence of a retained foreign body consistent with balloon fragments.

• Brand Name: KYPHON INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11567244
• MDR Text Key: 242161054
• Report Number: 9612164-2021-01145
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KY_UNK_PLASTY
• Device Catalogue Number: KY_UNK_PLASTY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR