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

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

Patient Problems Cardiac Arrest (1762); Encephalopathy (1833); Hematoma (1884); Paraplegia (2448)

Event Type  Death  

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.Although it is unknown whether the reported spinal system caused or contributed to the patient death, we are filling this mdr for notification purpose.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 spine implantable devices.This data was queried and grouped based on the specific 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 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- 325, gender- male ( female -116, male -207), age -64 years pre-operative diagnosis: degenerative disease (170 patient), trauma (108 patient), failed fusion (24 patient ), tumor (6 patient), deformity (14 patient), and infection ( 3 patient).Procedure performed: anterior cervical corpectomy and fusion (accf), anterior cervical discectomy and fusion (acdf), posterior spinal fusion (psf), open reduction and internal fixation (orif), posterior lumbar interbody fusion (plif).It was reported in the clinical titled" the vertex reconstruction system" with 06 month follow up or later that in the degenerative disease group, 67 of 170 patients were recorded as having an ae, in the trauma group, 48 of 108 patients were recorded as having an ae, in the failed fusion group, 11 of 24 patients were recorded as having an ae, in the deformity group, 6 of 14 patients were recorded as having an ae, in the tumor group, 3 of the 6 patients were recorded as having an ae, no reported aes were found for the infection group.The vertex system does not directly cause fusion to occur, it does provide posterior stability and fixation for the cervical and/or thoracic spine until fusion occurs.These high fusion success rates indicate that the vertex system is performing as expected.Overall, the findings from the clinical data collected on the vertex system support that the device is safe when used as indicated.Deaths were not expected to be caused by the device.Three patients expired secondary to complications exacerbated due to the pre-existing traumatic injury, including: 1- spinal cord injury with anoxic encephalopathy, 2- bradycardia with cervical fracture/hematoma, and 3- spinal cord injury, paraplegia, and respiratory failure, one patient expired following cardiac arrest, the other¿s cause of death is unknown.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 10157215
• MDR Text Key: 195229123
• Report Number: 1030489-2020-00634
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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): Death
• Patient Age: 64 YR