MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® FENESTRATED SCREW SET; DISPENSER, CEMENT

Model Number 6550202

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  Injury  

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having percutaneous spinal fixation for spinal fracture.It was reported that when the cement was ready to be used, the cement delivery guides with disposable tips were placed on the screws as per the surgical technique.The cement delivery device was then placed in the guide and the cement was delivered with the gun.Cement could not be visualized entering the vertebral body.The decision was made to move on to the next screw with similar results.The guides and tips were left in place for 3 min after cement delivery.When an attempt was made to remove the guides the tips were stuck in the head of the screws.While trying to remove the tips, it became clear that the cement did not go down the screw into the vertebral body, but spilled out into the head of the screws and around the screws. most of the cement ended up in the head of the screws and around the screw heads and had to be removed.Cement extravasation was detected intra-operatively.There was a delay to the total procedure time of more than 1 hour.The percutaneous procedure had to be changed mid case to a open procedure resulting in 2 long incisions and muscle disruption. there was no patient symptom reported.There were no further complications reported regarding the event.

Manufacturer Narrative

B2.Other: change of procedure from percutaneous procedure to an open procedure.H3.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17264412
• MDR Text Key: 318576622
• Report Number: 1030489-2023-00488
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6550202
• Device Catalogue Number: 6550202
• Device Lot Number: KH19H990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Date Device Manufactured: 04/17/2020
• 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 Outcome(s): Other