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

Catalog Number 9010000849

Device Problem Mechanical Problem (1384)

Patient Problem Thrombosis (2100)

Event Date 10/02/2019

Event Type  Death  

Manufacturer Narrative

Product was not 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.H10: 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 grasping of rod inserter loosened during rod insertion.Although the surgeon adjusted the grasping, the inserter could not grasp firmly and the inserter turned unstable in all directions.This product was a replacement after the first rod insertion malfunctioned in the same manner.Then, the event was dealt somehow and screw was tightened.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 instrument.When checking the rod inserter after the procedure, fine scratches on the tip gripping part were noticed but no problem was observed in operation and gripping function.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9264992
• MDR Text Key: 164573286
• Report Number: 1030489-2019-01240
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00643169537736
• UDI-Public: 00643169537736
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162494
• 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
• Device Catalogue Number: 9010000849
• Device Lot Number: KH19F038
• 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
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROD
• Patient Outcome(s): Death