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

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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- 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 hardware failure; 1 patient had hardware loosening.These recorded events were not related to the spinal system.One patient is recorded as having undergone a revision surgery due to hardware failure.Among the 23 patients included in this report, fusion status was available for 4 of the patients, and 2 of 4 were noted as having a successful fusion (50%).12 patients were recorded as having at least one ae.Of the 17 total aes recorded, 2 device-related aes were noted, which were not related to the spinal end cap system.

• 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 85281
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 10193665
• MDR Text Key: 201194598
• Report Number: 1030489-2020-00714
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/25/2020
• 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