MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CAPSTONE SPINAL SYSTEM

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

Patient Problems Wound Dehiscence (1154); Syncope (1610); Abscess (1690); Cardiac Arrest (1762); Fall (1848); Fatigue (1849); Failure of Implant (1924); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Seizures (2063); Sepsis (2067); Thrombosis (2100); Urinary Tract Infection (2120); Weakness (2145); Discomfort (2330); Injury (2348); Numbness (2415); Ambulation Difficulties (2544); Fibrosis (3167)

Event Type  Injury  

Manufacturer Narrative

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: 175 (male: 58, female: 117), ages: 12 years to 84 years, bmi: 17 kg/square-metre to 55.2 kg/square-metre procedure involved: anterior lumbar interbody fusion (alif), posterior lumbar interbody fusion (plif), transforaminal lumbar interbody fusion (tlif), posterior spinal fusion (psf) levels operated: lumbar, lumbar-sacral, thoracic-lumbar-sacral as per this clinical evaluation report, it was reported that a total of 175 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 three evidence groups for analysis: degenerative disease (159 patients), deformity (9 patients) and failed fusion (7 patients).Post-op, fusion assessment was performed for the patients where radiographic notes with fusion assessment were available.Of the 159 patients in the degenerative disease group, 84 patients had radiographic notes specifying fusion status in at least one of the follow-up timepoints.Successful fusion was noted for 66 of the 84 patients.No fusion was noted for 18 patients.Of the 9 patients in the deformity group, 4 patients 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.No fusion was noted for 2 patients.Of the 7 patients in the failed fusion group, 5 patients had radiographic notes specifying fusion status in at least one of the follow-up timepoints.Successful fusion was noted for all 5 patients.In the degenerative disease group, 81 patients were recorded to have suffered from adverse events (ae).In this group, a total of 261 aes, of 87 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: cardiac arrest (1), dural tear (1), sepsis (1), nerve breach (1).(b) events related to spine fusion surgery: adjacent segment changes (15), decreased peroneal cmap amplitude (1), epidural abscess (1), epidural fibrosis (1), epidural scarring of nerve root (1), facet arthropathy (1), foot drop (3), hemangioma (1), new or worsening pain (8), paravertebral spasm (2), pseudarthrosis (4), pseudomeningocele (1), postoperative radiculopathy (2), pressure in spine (1).(c) revision surgery: 16 patients are recorded as having undergone revision surgery due to adverse events not related to the device.Causes for the revision surgeries are as follows: adjacent segment degeneration (5), adjacent segment degeneration & epidural fibrosis (1), adjacent segment degeneration & hardware loosening (pedicle screw) (1), hardware removal/replacement-not specified rationale (1), hemangioma (1), nerve breach (pedicle screw) (1), postoperative radiculopathy (1), pseudarthrosis (1), and pseudarthrosis & hardware failure (pedicle screw) (1).Three patients underwent multiple revision surgeries.One patient underwent revision surgery due to a cortical bone breach by a pedicle screw and then a subsequent revision surgery for pseudarthrosis.The second patient underwent revision surgery due to continued degeneration at the index level(s) and a subsequent revision surgery due to a dural tear.A third patient underwent a revision surgery at the index level for unknown cause followed by a second revision surgery due to hardware failure (pedicle screw).(d) events related to continued thoracic/lumbar pain/discomfort: the primary complaints reported were associated with continued pain, stiffness, paresthesia, and muscle spasms.Overall, complaints associated with thoracic, lumbar, and lower extremity pain/discomfort account for 19 different aes and 99 total events.(e) events related to general surgery: surgical wound complications (12).(f) other aes that may be related to general surgery and/or spine surgery: balance issues (1), diabetic neuropathy (1), falls (13), fatigue (1), nodular density projection over lung (1), pancreatitis (1), seizures (1), syncope (1), urinary tract infection (1), and weakness (1).In the deformity group, 5 patients were recorded to have suffered from adverse events (ae).In this group, a total of 23 aes, of 13 different types were recorded.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 (2), new or worsening pain (2).(b) events related to continued thoracic/lumbar pain/discomfort: the primary complaints reported were associated with continued pain, stiffness, paresthesia, and muscle spasms and/or difficulty with activities of daily living secondary to pain.Overall, complaints associated with thoracic, lumbar, and lower extremity pain/discomfort account for 11 different aes and 22 total events.(c) events related to general surgery: deep vein thrombosis (1).In the failed fusion group, 6 patients were recorded to have suffered from adverse events (ae).In this group, a total of 39 aes, of 28 different types were recorded.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: new or worsening pain (2), pseudarthrosis (2).(b) revision surgery: pseudarthrosis (2).(c) events related to continued thoracic/lumbar pain/discomfort: the primary complaints reported were associated with continued pain, stiffness, paresthesia, and muscle spasms and/or complaints secondary to pain such as abnormal gait.Overall, complaints associated with thoracic, lumbar, and lower extremity pain/discomfort account for 12 different aes and 17 total events.(d) other aes that may be related to general surgery and/or spine surgery: balance issues (1), falls (2), urinary incontinence (1), weakness (2).In this retrospective observational study, high fusion success rates in patients across evidence groups were noted.Among the 175 patients included in this report, 92 patients were recorded as having at least one ae.There were 6 cases of pseudarthrosis and 21 cases of revision surgery noted.None of the reported revision surgeries can be directly attributed to the alleged peek 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-operative.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 alleged peek is safe and effective when used as intended.No new or emerging risks were identified.

• Brand Name: CAPSTONE SPINAL SYSTEM
• 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: 10177231
• MDR Text Key: 199250630
• Report Number: 1030489-2020-00680
• 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: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2020
• 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