MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VOYAGER FENESTRATED SCREWS; DISPENSER, CEMENT

Model Number 6550202

Device Problem Leak/Splash (1354)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

H6 - 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.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.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for collapse vertebral body at l1.It was reported that the surgeon instrumented screws at t10-11, and l2-3.The screws were then filled with cement (kyphon hv-r ref c01a).The cement was mixed according to the surgical technique and consistency was checked before being inserted into the delivery guide.The bone filling device that was used was kyphon express ref f06a.It was informed these were the substitute for the cement delivery device (6550102).After the cement was introduced, the bone filler device and obturator were left in the delivery cannula and removed after 3min per the surgical technique.Once the delivery cannula was removed, the disposable delivery tip was left in several of the tulips.These had to be retrieved.After the rod was inserted, the set screws were placed but 3 of the screws did not allow the rod to fully set.It was discovered that cement was in the tulip of the screws.The cement had to be drilled out of each tulip before the set screws were able to be fully tightened and torqued off. it is unclear if the cement leakage was related to the product.The procedure was completed by the original product.Products were discarded by the customer.There were no patient symptoms or complications reported as a result of this event.Additional information received from manufacturer representative that the procedure involved was fusion of t10 ¿ l3 vertebrae.There was a delay of 120 minutes in the overall procedure time due to this event.The cement was not leaked in to the patient body.

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.

Event Description

Additional information received from manufacturer representative that exposure to the screw tulip was increased to allow for visualization of the screw.Curettes were then used to remove cement from screw tulip before inserting rods.There were no unintended equipment used due this delay in procedure.

• Brand Name: VOYAGER FENESTRATED SCREWS
• 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: 17077145
• MDR Text Key: 316679029
• Report Number: 1030489-2023-00403
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00763000211035
• UDI-Public: 00763000211035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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: KH19J702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female