MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problem Malposition of Device (2616)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2016 the patient presented with spondylolisthesis and mild stenosis at l5-s1 and left leg weakness.The patient underwent: l5 decompressive laminectomy; interbody graft at l5-s1; pedicle screw instrumentation at the l5-s1 level.As per the op-notes, the spinous processes at l4-l5 and s1 had been exposed, the distal probe was fixed to the s1 spinous process and an o-arm scan was taken and confirmed the position.The disk space was prepared for the interbody graft using a variety of disk removal instruments.Once the disk space was thoroughly evacuated, a small bone graft was placed into the disk space and pushed over to the contralateral side.A trial 9 mm graft was put into place under o-arm guidance.A final 9 x 22 mm cage was selected and packed with foam.The graft was put into place using the mallet until the bottom of the cage was flush with the surrounding vertebral bodies.O-arm confirmed that the graft was both deep enough and extended across the mid-line.The needle was next used to cannulate the right-sided l5 pedicles through the existing incision.O-arm confirmed needle position on the upper outer pedicle edge.The needle was advanced into the vertebral body under o-arm guidance.A tap was then slid down along the same trajectory and advanced into the vertebral body.An appropriate length screw was chosen based on imaging.The tap was removed and the screw was seated into the bone.The screw was advanced until fully and firmly seated into the vertebral body as seen on ct.The screw handle was then done from the screw tower.The procedure was repeated for the remaining three pedicles, including the left-sided l5 and bilateral s1.Once the screws were in place, the rod delivery system was attached to the left-sided screw towers and an appropriately sized rod was gently moved into place down the towers and onto the screw heads.The rod tester did confirm that the rod did go through both screw heads.The rod was secured using two set screws.This process was repeated on the right side and a rod was put into place and secured with two set screws.Reportedly, intra-op, the pedicle screw was noted to have breached significantly medial to the pedicle right l5 precisely where the existing nerve roots lie.As a direct result of the misplaced pedicle screw, the patient has permanent nerve damage.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7271077
• MDR Text Key: 100092005
• Report Number: 1030489-2018-00212
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/14/2018
• 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