MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number G7752535

Device Problem Material Deformation (2976)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

This product is not approved for sale in us but a similar device with catalog# 7752526,510k # k082728 and udi (b)(4) is approved for sale in us.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a field contact regarding a product used in spinal therapy.It was reported that the crosslink was placed between rods of c4/5.When attempted to perform break-off of the left set screw, the set screw stripped.When the implant was replaced with a new one and performed break-off with the same driver, the final tightening was completed without problems.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The product will be returned and was replaced.Device status reason : explanted-complete a total of 3 crosslinks were used, and set screws of 2 crosslinks were stripped (this report is for one of them).At the time of final tightening, the left set screw stripped.Therefore, a new one was opened and used, and it was able to tighten this one with the same driver.The counter was not used.The physician said that stripping often occurs with this product.There was a delay in the overall procedure time.Procedure/therapy: posterior cervical fixation levels implanted: c4/5 pre-operative diagnosis: dropped head syndrome.The delay was about 5-10 minutes.There was a patient involved but there was no health damage/effect on the patient.

Manufacturer Narrative

Device evaluation summary: product analysis #267692202:g7752535 lot# 0716756w visual and optical examination identified that the breakage is consistent with excessive torque applied during tightening of the cen tral nut.This is consistent with over torque.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: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 11796662
• MDR Text Key: 249755422
• Report Number: 1030489-2021-00588
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7752535
• Device Catalogue Number: G7752535
• Device Lot Number: 0716756W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2019
• 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