MAUDE Adverse Event Report: GENESYS SPINE TILOCK PEDICLE SCREW SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number SEE ATTACHED EVALUATION SUMMARY

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 04/19/2019

Event Type  Injury  

Event Description

A patient underwent a 2-level lumbar fusion from l4 - s1 on (b)(6) 2019.During the initial procedure the surgeon had difficulty starting two g828 lock screws, both on the same side of the construct.The surgeon was using low-top tilock screws but, due to the patient anatomy, the rod did not seat well within the screw tulips.The surgeon tried to force the rod into the tulips then began threading the lock screws but had difficulty starting the thread for both screws.He tried backing the lock screws out and restarting but he was unsure if they were cross threaded.The surgeon did use the final torque shaft to final torque the screws.On the contralateral side the rod and lock screws were applied without issue.Roughly three weeks after the initial surgery the patient fell and proactively returned to the doctor even though they were not experiencing any symptoms.A precautionary x-ray was performed which revealed that one of the rods had migrated from the screws.The rod that migrated was on the side that the doctor had difficulty seating the rod and starting the lock screws.The surgeon elected to perform a revision surgery to address the issue.During the revision surgery the surgeon inspected the hardware and stated that he had cross-threaded the lock screws.Both of the cross-threaded lock screws were removed and discarded.The surgeon felt the remaining hardware was in good shape so he reseated the rod and secured it with two new lock screws.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx hwy; building 3, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE
• Manufacturer Contact: andrew davison ; 1250 s. capital of tx hwy; building 3, suite 600; austin, TX 78746 ; 5123817071
• MDR Report Key: 8636182
• MDR Text Key: 145935979
• Report Number: 3008455034-2019-00003
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE ATTACHED EVALUATION SUMMARY
• Device Catalogue Number: SEE EVALUATION SUMMARY
• Device Lot Number: SEE EVALUATION SUMMARY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention