MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTEX® RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 6950315

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2021

Event Type  Injury  

Event Description

Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis- chin on chest deformity involved in the posterior cervical fusion.Addition of occipital plate and rods to existing implant construct.Levels im planted- occiput to t2.It was reported that post-operatively, the occipital rod mechanism "fell apart" shortly after surgery on (b)(6) 2017.They decided to treat the patient with a halo device rather than another surgery to replace failed implants.The patient eventually had difficulty looking straight ahead, so they scheduled a revision of the occipital rods and correction of the sagittal deformity.The patient incurred a vascular injury during the revision on 10/19/2021 and they were unable to complete the surgery.On 2021-oct-22, received additional information that patient had suffered a major stroke.It has also been reported to that patient had passed around 6pm on (b)(6) 2021.On 2021-oct-27, received additional information that as per a/p x-ray image on (b)(6) 2017, the hinge of the rod on the right was disconnected.On the lateral x-ray image of (b)(6) 2017 the proximal extension of the rod that connects to the occipital plate was away.Set screw holds the rod to the plate.Plate holds the occipital rod.Vascular injury occurred during corrective manipulation of head/neck, and it was not due to mdt product.Stroke occurred because of vascular injury during corrective manipulation of head/neck, and it was not due to mdt products.Revision surgery was performed with mdt products, just the occipital plate and hinge rods.

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.

Manufacturer Narrative

H3: device evaluated summary- visual and optical examination identified that the set screw has a defined angle to the node indicating a more defined angulation to the rod.There are witness marks on the face of this screw indicative of rod movement.It would appear that there may have been some angulation as it relates to the set screw face and the rod.The hex and the threads are damaged which appears to be from misalignment and over load.Additional information: d9, g3, h3 and h6.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12817966
• MDR Text Key: 280831281
• Report Number: 1030489-2021-01385
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00885074451237
• UDI-Public: 00885074451237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052180
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6950315
• Device Catalogue Number: 6950315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female