MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. VERTE-STACK CORNERSTONE SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problems Stroke/CVA (1770); Failure of Implant (1924); Unspecified Infection (1930); Pneumonia (2011); Ulcer (2274); Respiratory Failure (2484); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Aes have been mentioned.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- 23 patient, gender- (15 male, 9 female), age (mean age)- 58.9 years pre-op diagnosis: degenerative disease (17 patient) and trauma (6 patient) procedure involved: anterior cervical corpectomy and fusion (accf), anterior cervical discectomy and fusion (acdf), posterior spinal fusion (psf), open reduction and internal fixation surgery (orif) it was reported in the clinical study that a total of 23 patients met the minimal inclusion criteria of having a clinical diagnosis and documented surgical implantation of spinal endcaps with the strut.Based on the charted diagnoses, patients were stratified into one of two evidence groups: degenerative disease (17 patient) and trauma (6 patient).In the degenerative disease group, 4 out of 17 patient had radiographic notes specifying fusion status in at least one of the follow-up timepoints.Successful fusion was noted for 2 of the 4 patients at the last radiographic assessment specifying fusion status.9 of 17 patients were recorded as having an ae.In total, 12 aes were recorded across 9 different types of aes.1 patient had stroke.These recorded events were not related to the spinal system.2 patient had adjacent segment changes; 1 patient had pseudarthrosis.Two patients are recorded as having undergone a revision surgery.The cause for the revision surgery is as follows: pseudarthrosis in 1 patient, and not specified in 1 patient.1 patient had upper extremity paresthesia.1 patient had hospital-acquired infection.1 patient had pulmonary nodular amyloidosis.In the trauma group, fusion assessments were not available for the trauma evidence group.3 of 6 patients were recorded as having an ae.In total, 5 aes were recorded across 4 different types of aes.1 patient had pneumonia, 1 patient had respiratory failure.Among the 23 patients included in this report, fusion status was available for 4 of these patients, and 2 of 4 were noted as having a successful fusion (50%).12 patients were recorded as having at least one ae.The reported serious aes are not anticipated to be device-related.

• Brand Name: VERTE-STACK CORNERSTONE SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 10193626
• MDR Text Key: 201218145
• Report Number: 1030489-2020-00713
• Device Sequence Number: 1
• Product Code: NKB
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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: 05/26/2020
• 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): Other; Required Intervention