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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent posterior spinal fusion(psf) in combination with balloon kyphoplasty (bkp) at l1/l3 due to l2 compression fracture.During the procedure, 4 small parts (convex part of the extender tip) inside the extender were worn.It seemed that the force of gripping a screw was weak.When pushing down the rod of l2 by sequential reducer, the extender deviated from the screw during rod tightening and became loose.Since the rod had almost been pushed down onto the screw head, it was not replaced, and the set screw was placed as it was and the operation was completed.A cross thread occurred when trying to provisionally fixing the set screw for the first time under condition of extender deviated.Washing was performed since there was metal piece.The extender was removed, and looked for the screw head directly to perform placement.This event occurred after bkp operation was performed at l2 and set screws were placed at l1 and l3.There was a delay of less than 60 minutes in procedure time due to this event.No patient complications were reported.

Manufacturer Narrative

Product analysis: the extender has visible signs of wear but would still function properly.If information is provided in the future, a supplemental report will be issued.

• 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; 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: 8202402
• MDR Text Key: 131592441
• Report Number: 1030489-2018-01708
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169177055
• UDI-Public: 00643169177055
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122862
• 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,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7578302
• Device Lot Number: EM15E022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• 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