MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; GONIOMETER, NONPOWERED

Catalog Number 5484805

Device Problems Disconnection (1171); Mechanical Problem (1384)

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

Event Date 06/20/2018

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 r eported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-op diagnosis: lumbar spinal canal stenosis procedure: transforaminal lumbar interbody fusion (tlif) levels implanted: l3/4/5 it was reported that on (b)(6) 2018, intra-op, the screws were inserted without problem at first, and 4mm reduction screw was placed only for l3.There was also no problem with inserting the rod, and it was placed on l4/5 until "rd" and provisional fixation was performed, and there was no problem with the provisional fixation on the left side.The provisional fixation was performed on the right side of l4, and when l5 set screw was attempted to be inserted, the situation was that it could not be tightened until the end although it gripped in the middle.When the set screw was checked, it was confirmed that it was gouged.No matter how many times the surgeon tried with new set screws, there was no effect.It was suspected that there might be something wrong with the screw head.Therefore, the screw was removed and replaced with a new screw, and the new screw was inserted again.The rod was placed and the provisional fixation was attempted to be performed, but it could not be performed again on the right side of l5.When checking it by image, it was obvious that the extender was disengaged, so the screw was removed again.As there was a backup extender, this one was used instead, and then there was no problem with the tightening.No patient complications were reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: GONIOMETER, NONPOWERED
• 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: 7693327
• MDR Text Key: 114677430
• Report Number: 1030489-2018-01010
• Device Sequence Number: 1
• Product Code: KQW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102807
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2013
• Device Catalogue Number: 5484805
• Device Lot Number: RS11M037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1