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

Model Number G7756067

Device Problem Material Deformation (2976)

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

Event Date 08/18/2021

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.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 the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during a revision surgery of anterior cervical c6 vertebral body replacement and c5-t1 posterior fixation.Patient had undergone an initial surgery of c5/6/7 acdf for the diagnosis of c6 vertebral body fracture.It was reported the physician pointed out that the hexagonal driver shaft was unstable when inserted at the time of final tightening.The point of hexagonal part at the tip of the driver might have been rounded.Screw stripping occurred when the set screw, lateral connector, and crosslink were finally tightened.Screws were stripped on both sides of c5 out of 8 set screws.Stripping occurred with one of the two lateral connectors (one site on the screw side of the lateral connector).Stripping occurred with 1 (right side) out of 2 crosslinks.The driver stripped with multiple set screws at the time of final tightening.From the final tightening of the first one, there was a feeling of strangeness with the connection between the driver and the set screw.The set screws and lateral connector have been discarded.Crosslink remains in the body.No patient injury / complication was reported.

Manufacturer Narrative

D6a, d6b: implant and explant date was updated.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
• MDR Report Key: 12495107
• MDR Text Key: 272147425
• Report Number: 1030489-2021-01172
• Device Sequence Number: 1
• Product Code: KWP
• 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
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7756067
• Device Catalogue Number: G7756067
• Device Lot Number: 0682431W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1