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

Model Number 6550202

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having tlif.It was reported that the screws were placed and the surgeon wanted to cement down the screw during the fluroscopy.The cement did not progress out of the fenestrated holes and then it leaked up towards the spinal canal so further steps were included in the operation to clear the cent.Further into the operation, it was impossible to seat the rod as the cement had damaged the screw head.The screw was then pulled out and had to be replaced.The event added 3 hours into the length of the surgery. there was no patient symptom reported.There were no further complications reported regarding the event.Additional information was received that the cement had leaked into the screw head and into surrounding tissue so they had to clear both, eventually ending with the screw pulling out and they had to reposition the screw, putting cement into the screw track first and then putting the new screw in.

Manufacturer Narrative

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: 16741006
• MDR Text Key: 313303914
• Report Number: 1030489-2023-00260
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 20763000211039
• UDI-Public: 20763000211039
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6550202
• Device Catalogue Number: 6550202
• Device Lot Number: KH19L718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Date Device Manufactured: 09/02/2022
• 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 Sex: Male