MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. CERVICAL MANAGEMENT BASE UNIT; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 5979-1

Device Problems Device Slipped (1584); Output Problem (3005); Positioning Problem (3009)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/09/2022

Event Type  Injury  

Event Description

Patient with severe c-spine fracture and severe instability following a fall.The patient was prepped to undergo a posterior c1-c3 nonsegmental instrumentation, fusion, and laminectomy.Baseline somatosensory and motor evoked potentials were obtained and followed throughout the case.A mayfield headrest and mizuho cervical management system was applied in the usual sterile fashion.The patient was positioned supine, then sandwiched and flipped prone.According to the operative note, attention to detail to the mayfield cervical spine head rest was checked multiple times for stability and it was achieved.Imaging revealed adequate position of c-spine.After the exposure of the fracture was completed, there was complete subluxation and translation of the patient from posterior to anterior due to slippage of the cervical management system.Two surgeons helped reestablish stability with the cervical management system, checking all connections.The surgeon proceeded to check the cervical management system before rescrubbing and proceeding with the case.Following the slippage, the surgeon also noticed that the neuromonitoring leads were displaced.These were replaced by the monitoring physiologist and revealed complete loss of all motor evoked potential (bilateral upper and lower extremities).Following this, the surgeon proceeded to decompress the cord as well.There was return in the somatosensory evoked potentials towards baseline, but not motor evoked potentials.The cervical management system continued to slip and fail 2 additional times.The assisting surgeons proceeded to stand underneath the drapes and hold the patient's head in the best anatomic position to proceed with partial instrumentation.Because of the patient's physiologic cardiac instability, the intraoperative slippage of the mayfield headrest, and the loss of the motor evoked potentials and somatosensory evoked potentials, the surgeon decided to only do a different type of fixation, which he noted as not being biomechanically optimal.According to the surgeon, his goal was to quickly complete the procedure, in order to.

Event Description

Patient with severe c-spine fracture and severe instability following a fall.The patient was prepped to undergo a posterior c1-c3 nonsegmental instrumentation, fusion, and laminectomy.Baseline somatosensory and motor evoked potentials were obtained and followed.A mayfield headrest and mizuho cervical management system (cms) was applied.The patient was positioned supine, then sandwiched and flipped prone.Mayfield headrest was checked multiple times for stability, and it was achieved.Imaging revealed adequate position of c-spine.After the exposure of the fracture was completed, there was complete subluxation and translation of the patient from posterior to anterior due to slippage of the cervical management system.Two surgeons helped reestablish stability with the cms, checking all connections.The surgeon proceeded to check the cms before rescrubbing and proceeding with the case.Following the slippage, the surgeon also noticed that the neuromonitoring leads were displaced.These were replaced by the monitoring physiologist and revealed complete loss of all motor evoked potential (bilateral upper and lower extremities).Following this, the surgeon proceeded to decompress the cord as well.There was return in the somatosensory evoked potentials towards baseline, but not motor evoked potentials.The cms continued to slip and fail 2 additional times.The assisting surgeons proceeded to stand underneath the drapes and hold the patient's head in the best anatomic position to proceed with partial instrumentation.Because of the patient's physiologic cardiac instability, the intraoperative slippage of the mayfield, and the loss of the motor evoked potentials and somatosensory evoked potentials, the surgeon decided to only do a different type of fixation, which he noted as not being biomechanically optimal.Surgeon stated his goal was to quickly complete the procedure, in order to examine the patient and establish the patient's neurologic examination upon wakening.Following the surgery, the patient was transferred to the sicu.Five days later, the patient was discharged home.

Event Description

Patient with severe c-spine fracture and severe instability following a fall.The patient was prepped to undergo a posterior c1-c3 nonsegmental instrumentation, fusion, and laminectomy.Baseline somatosensory and motor evoked potentials were obtained and followed.A mayfield headrest and mizuho cervical management system (cms) was applied.The patient was positioned supine, then sandwiched and flipped prone.Mayfield headrest was checked multiple times for stability, and it was achieved.Imaging revealed adequate position of c-spine.After the exposure of the fracture was completed, there was complete subluxation and translation of the patient from posterior to anterior due to slippage of the cervical management system.Two surgeons helped reestablish stability with the cms, checking all connections.The surgeon proceeded to check the cms before rescrubbing and proceeding with the case.Following the slippage, the surgeon also noticed that the neuromonitoring leads were displaced.These were replaced by the monitoring physiologist and revealed complete loss of all motor evoked potential (bilateral upper and lower extremities).Following this, the surgeon proceeded to decompress the cord as well.There was return in the somatosensory evoked potentials towards baseline, but not motor evoked potentials.The cms continued to slip and fail 2 additional times.The assisting surgeons proceeded to stand underneath the drapes and hold the patient's head in the best anatomic position to proceed with partial instrumentation.Because of the patient's physiologic cardiac instability, the intraoperative slippage of the mayfield, and the loss of the motor evoked potentials and somatosensory evoked potentials, the surgeon decided to only do a different type of fixation, which he noted as not being biomechanically optimal.Surgeon stated his goal was to quickly complete the procedure, in order to examine the patient and establish the patient's neurologic examination upon wakening.Following the surgery, the patient was transferred to the sicu.Five days later, the patient was discharged home.

• Brand Name: CERVICAL MANAGEMENT BASE UNIT
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587
• MDR Report Key: 16435127
• MDR Text Key: 310293823
• Report Number: 16435127
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5979-1
• Device Catalogue Number: 5979-1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26645 DA
• Patient Weight: 66 KG
• Patient Race: White