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

Model Number REFER TO EVALUATION SUMMARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

It is well publicized that revision surgeries are commonly required after primary fusion surgery.In this case, progressive degradation of the lumbar spine and associated disk disease led to the need to treat the level above the original tilock construct.Since the levels initially treated were properly fused, the hardware was in-tact & well placed, and there were no signs of infection it was determined that the hardware performed as intended.The genesys spine implants did not contribute to the progression of the underlying disease.

Event Description

On (b)(6) 2016 a patient underwent a three-level lumbar fusion at l3-l4, l4-l5, and l5-s1.On (b)(6) 2018 the patient underwent revision surgery due to extend the construct due to progression of the underlying disease.At the time of the revision the pedicle screws were found to be in-tact and well placed.The patient had fused at all levels treated prior.The surgeon chose to only remove the rods and lock screws; the original pedicle screws were left in the patient and two additional screws & rods were implanted to extend the construct.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, PRODUCT CODE
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of texas hwy; bld three, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE; austin TX 78746
• Manufacturer Contact: william sowers ; 1250 s. capital of texas hwy; bld three, suite 600; austin, TX 78746 ; 5123817080
• MDR Report Key: 7623261
• MDR Text Key: 111835289
• Report Number: 3008455034-2018-00004
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REFER TO EVALUATION SUMMARY
• Device Catalogue Number: REFER TO EVALUATION SUMMARY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2011
• 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
• Patient Age: 66 YR
• Patient Weight: 91