MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTE-STACK SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number G9196007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from healthcare provider (hcp) via field representative regarding patient with lumbar spinal canal stenosis involved in posterior lumbar interbody fusion (plif).It was reported during use, there was patient symptoms or complications reported due to superior adjacent segment disease.As a result, revision surgery was scheduled on (b)(6) 2020.It was scheduled for extending on one intervertebral disc and connecting by degenerative disc + vertebral 5 (dd+v5).Levels implanted- l4/5.It was reported there is no malfunction of implanted instrument in the patient, but decompression and fixation was necessary between the upper level of vertebral bodies.Back pain appeared around (b)(6) 2020 due to a work of keeping sitting.It was said that the pain on the lateral of the thigh did not improve due to block, so the operation was performed.Received additional information that, there was a status at l4/5, tlif had been performed using legacy and boomerang.Olif was performed at anterior l3/4.Rod was removed from posterior, and screw was inserted into l3 by v5.L3, l4 and l5 were connected by rod and the operation was completed.Reported, immediately after operation, movement of legs were good.Patient has recovered.

Manufacturer Narrative

Correction: g5: similar device with catalog # 9196007, 510k # k040167 and udi # (b)(4) is marketed in the united states.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

Information was received from healthcare professional via field representative regarding patient with symptoms of lumbar spinal canal stenosis involved in posterior lumbar interbody fusion (plif) procedure used in spinal therapy.It was reported during use, there was patient symptoms or complications reported due to superior adjacent segment disease.As a result, revision surgery was scheduled on (b)(6) 2020.It was scheduled for extending on one intervertebral disc and connecting by degenerative disc + vertebral 5 (dd+v5).Levels implanted- l4/5.It was reported there was no malfunction of implanted instrument in the patient, but decompression and fixation was necessary between the upper level of vertebral bodies.Back pain appeared around (b)(6) 2020 due to a work of keeping sitting.It was said that the pain on the lateral of the thigh did not improve due to block, so the operation was performed.Received additional information that at l4/5, tlif had been performed using legacy and boomerang.Olif was performed at anterior l3/4.Rod was removed from posterior, and screw was inserted into l3 by v5.L3, l4 and l5 were connected by rod and the operation was completed.Reported immediately after operation, movement of legs were good.Patient had recovered.Patient medical history: benign tumor of left hip joint, multiple fibroid of uterus, glandula thyreoidea, generalized scleroderma.Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.

Manufacturer Narrative

H10: review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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: VERTE-STACK SPINAL SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw,in TN 46582
• MDR Report Key: 10499386
• MDR Text Key: 206099389
• Report Number: 1030489-2020-01201
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: G9196007
• Device Catalogue Number: G9196007
• Device Lot Number: 0044420W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/07/2020
• Supplement Dates Manufacturer Received: 08/12/2020; 08/12/2020
• Supplement Dates FDA Received: 09/11/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 46