MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Failure to Align (2522)

Patient Problem Thrombosis (2100)

Event Date 10/02/2019

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 this product caused or contributed to the reported event, we are filling this mdr for notification purpose.Hcp review results: this event is related to the surgery and has no cause-effect relationship with the device.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent percutaneous pedicle screw fixation at posterior side of t11-l5 due to l2 vertebral body fracture from a tumble.Intra-op, the set screw on the left side of l3 did not engage with the screw even though it was pushed.Although the set screw was caught on, it idled during tightening.The tab extender cap had been attached, but the tab of the screw broke; so, the surgeon tried skin incision but the set screw did not engage.The screw was explanted and a bigger set screw was inserted again.There was a gap noted between the rod and the screw head as well.The procedure was delayed by less than 60 minutes due to this event.Post-op, after final tightening and wound closure was done without problems, when patient's position was changed to supine position, patient's condition had a sudden deterioration and the nurse reported the color of patient's feet was not good.The condition turned to a cardiac arrest state and treatment was performed at the operation room for more than an hour.The reason suspected for health deterioration was reported that when setting position, although vertebral body reduction had been performed, it was felt that the anterior side of the vertebral body opened during the operation.According to the doctor, this occurred maybe because the pillow placed at the abdomen displaced during the operation, and the unintended part was pressed due to the displacement.The patient was then transferred to icu in the state that "vf" still did not return.Then, at a later date, on (b)(6) 2019, it was heard that the patient had died.The cause of death was reported as pulmonary thrombosis.The doctor reported that the death was attributable to the release from the compression of groin; and not related to the malfunction of the implant.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 9264990
• MDR Text Key: 164573098
• Report Number: 1030489-2019-01239
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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
• Date Manufacturer Received: 10/02/2019
• 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
• Treatment: SCREW, ROD
• Patient Outcome(s): Death