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

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

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Fall (1848); Inflammation (1932); Pain (1994); Injury (2348); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Other: adverse events reported.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.Total patients: 86 (male: 38, female: 48), ages: 33 years to 84 years, bmi: 20.2 kg/square-metre to 53.1 kg/square-metre procedure involved: oblique lumbar interbody fusion (olif), transforaminal lumbar interbody fusion (tlif), posterior spinal fusion ( psf), posterior lumbar interbody fusion (plif).Levels operated: lumbar, lumbar-sacral, thoracic.As per this clinical evaluation report, it was reported that a total of 86 patients having a clinical diagnosis and documented surgical implantation of the alleged spinal system were followed-up.Based on the radiographic diagnoses, patients were stratified into one of the three evidence groups for analysis: degenerative disease (73 patients), deformity (10 patients), failed fusion (3 patients).Post-op, fusion assessment was performed for the patients where radiographic notes with fusion assessment were available.Of the 73 patients in the degenerative disease group, 58 patients had radiographic notes specifying fusion status in at least one of the follow-up timepoints.Successful fusion was noted for all the 58 patients.The 10 patients in the deformity group and the 3 patients in the failed fusion group had successful fusion as well.Fusion assessment prior to 3-months post-operative are less reliable and have not been included in the analysis.In the degenerative disease group, 20 patients were recorded to have suffered from adverse events (ae).In this group, a total of 36 aes, of 16 different types were recorded.The following are the adverse events reported in this group with the number of events mentioned in brackets "()": (a) serious adverse event: cerebrospinal fluid leak (1), discitis (1), dural tear (1), osteomyelitis (1) and surgical wound infection (deep) (1) are expected to be complications associated with general surgery.(b) events related to spine fusion surgery: adjacent segment changes (12) and new or worsening pain (2).(c) revision surgery: 3 events of revision surgery were noted.Causes for the revision surgeries are as follows: cerebrospinal fluid leak (1), deep wound infection/hardware loosening/osteomyelitis/discitis (1), dural tear (1).(d) events related to continued thoracic/lumbar pain/discomfort: chronic pain (1).(e) events related to general surgery: surgical wound incision <(>&<)> drainage (1).(f) other aes that may be related to general surgery and/or spine surgery: falls (1) and low hemoglobin count (1).In the deformity group, 2 of the 10 patients were recorded as having an ae.In total, 3 aes were recorded across 3 different ae types.The following are the adverse events reported in this group with the number of events mentioned in brackets "()": (a) events related to spine fusion surgery: adjacent segment changes (1).(b) events related to general surgery: surgical wound infection (1) and surgical wound incision <(>&<)> drainage (1).In the failed fusion group, 1 patient reported adjacent segment changes.This event was determined to be related to spine fusion surgery.The serious aes are not expected to be caused by the reported spinal system.Other reported aes were known complications associated with continued pain/discomfort, spine fusion surgery, or general surgery.It is important to note that patients often present with pain, motor, or neurologic deficits pre-operatively.While surgical intervention may reduce pain or improve symptoms, it may not completely resolve all symptomology, which may account for some of the cases of continued discomfort or pain.Overall, the results from this retrospective observational study indicate that the reported spinal system is safe and effective when used as intended.No new or emerging risks were identified.

• Brand Name: ELEVATE 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: 10153952
• MDR Text Key: 195241655
• Report Number: 1030489-2020-00615
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• 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: 05/18/2020
• 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