MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. VERTE-STACK SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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

Patient Problem Patient Problem/Medical Problem (2688)

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

A multi-center retrospective observational study was conducted to obtain post-market clinical data for medtronic spine implantable devices.This data was queried and grouped based on the specific medtronic system used in the surgical procedure and analyzed to establish real-world evidence (rwe) for the performance and safety of the device in question when used as part of standard clinical practice.This data collection is one part of ongoing post-market clinical surveillance activities that are intended to confirm and monitor the safety and performance of the device.This report summarizes the clinical data obtained by medtronic as part of this retrospective observational study.Data obtained as part of this study was provided to in a de-identified format and thereby provides no patient or product specific identifiers.Patient demographics: no.Of patients- 95, gender- male ( female - 45, male - 50), age - 51.25 years pre-operative diagnosis: degenerative disease (88 patient), failed fusion (03 patient ), deformity (02 patient) and trauma (02 patient).Procedure performed: anterior cervical discectomy and fusion (acdf) it was reported in the clinical titled" the verte-stack cornerstone spinal system " with 06 month follow up or later that in the degenerative disease group, 70 of 88 patients were recorded as having an ae, in the failed fusion group, 3 of 3 patients were recorded as having an ae, in the deformity group, 1 of 2 patients were recorded as having an ae, in the trauma group, 0 of 2 patients were recorded as having an ae.Overall, within this patient population the verte-stack cornerstone system when used in this manner is safe and the performance is consistent with what would be expected from other acdf procedures.There were 02 reports of revision surgery.The causes of the revision surgery are as follows: adjacent segment changes (1), pseudarthrosis (1).

• Brand Name: VERTE-STACK SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 10182931
• MDR Text Key: 201178310
• Report Number: 1030489-2020-00694
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: No
• 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