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

Model Number SEE ATTACHED EVALUATION SUMMARY

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

Patient Problem No Information (3190)

Event Date 07/10/2018

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 and thoracic spine and associated disk disease led to the need to treat the three levels above the original tilock construct.Three of the four levels initially treated had properly fused, there were no signs of infection, and the hardware performed as intended.The genesys spine implants did not contribute to the progression of the underlying disease.

Event Description

On (b)(6) 2017 a patient underwent a four-level lumbar fusion at l2-l3, l3-l4, l4-l5, and l5-s1.On (b)(6) 2018 the patient underwent revision surgery to extend the construct due to progression of the underlying disease.At the time of the revision the pedicle screws were found to have performed as intended.The patient had fused at three out of the four levels treated prior.The surgeon chose to only remove and replace the hardware at l2; the other original hardware was left in the patient and the construct was extended three more levels to t11.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx highway; building 3, suite 600; austin,
• Manufacturer (Section G): GENESYS SPINE; 1250 s. capital of tx hwy; building 3, suite 600; austin TX 78746
• Manufacturer Contact: andrew davison ; 1250 s. capital of tx hwy; building 3, suite 600; austin,
• MDR Report Key: 7748706
• MDR Text Key: 116044874
• Report Number: 3008455034-2018-00005
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K100757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/03/2018

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: SEE ATTACHED EVALUATION SUMMARY
• Device Catalogue Number: SEE ATTACHED EVALUATION SUMMAR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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: 67 YR
• Patient Weight: 68