MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CAPSTONE CONTROL 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); Arthritis (1723); Hematoma (1884); Failure of Implant (1924); Pain (1994); Weakness (2145); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Adverse events 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.Total patients: 174 (male: 60, female: 114), ages: 30 years to 84 years, bmi: 19.8 kg/square-metre to 55.1 kg/square-metre procedure involved: transforaminal lumbar interbody fusion (tlif), posterior spinal fusion (psf) levels operated: lumbar, lumbar-sacral.As per this clinical evaluation report, it was reported that a total of 174 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 four evidence groups for analysis: degenerative disease (169 patients), deformity (1 patient), failed fusion (3 patients) and infection (1 patient).Post-op, fusion assessment was performed for the patients where radiographic notes with fusion assessment were available.Of the 169 patients in the degenerative disease group, 99 patients had radiographic notes specifying fusion status in at least one of the follow-up timepoints.Successful fusion was noted for 98 of the 99 patients.No fusion was noted for 1 patient.The patient in the deformity group was noted to have a successful fusion.Of the 3 patients in the failed fusion group, 2 had radiographic notes specifying fusion status in at least one of the follow-up timepoints.Successful fusion was noted for the two patients.Fusion status for 1 patient was not specified.The patient in the infection group was noted to have a successful fusion.In the degenerative disease group, 18 patients were recorded to have suffered from adverse events (ae).In this group, a total of 29 aes, of 18 different types were recorded.The following are the adverse events reported in this group with the number of events mentioned in brackets "()": serious adverse event: epidural hematoma (1) requiring a revision surgery.Events related to spine fusion surgery: adjacent segment changes (4), foot drop (1), lumbar degeneration (1), pseudoarthrosis (1), two cases of hardware failure related to broken s1 pedicle screws and not related to the implants under this study.Revision surgery: 7 instances reported.The reasons for revision surgery are as noted: adjacent segment changes (1), epidural hematoma (1), and not specified (5).Events related to continued thoracic/lumbar pain/discomfort: illiotibial band syndrome (1), lower back pain (1), lower extremity pain (2), and lower extremity weakness (1).Events related to general surgery: surgical wound dehiscence (1), and surgical wound infection (1).Other aes that may be related to general surgery and/or spine surgery: balance issues (1), osteoarthritis (1).In the deformity group, one patient experienced loosening of s1 pedicle screw, which is not an implant captured in this study.In the failed fusion group, one patient had a malpositioned pedicle screw that migrated and breached the cortical bone, requiring revision surgery.This event is expected to be a result of the spine surgical procedure and is not related to the implants captured in this study.In the infection group, no data for adverse event was reported.Overall, the results from this retrospective observational study indicate that the alleged spinal system is safe and performs as int ended.No new or emerging risks were identified.

• Brand Name: CAPSTONE CONTROL 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: 10154047
• MDR Text Key: 195900698
• Report Number: 1030489-2020-00624
• 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
• 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