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 05/03/2019

Event Type  Injury  

Manufacturer Narrative

The complainant reported that the patient had "crazy poor" bone quality that led to the screws being loose and the subsequent need for a removal and revision surgery more than nine months after the initial procedure.The surgeon removed all tilock hardware and replaced it with a competitor's fenestrated screw system in order to inject pmma (bone cement) to help stabilize the new pedicle screws.It is not known if there are any factors (smoking, alcohol use, medications, etc.) that would have contributed to the patient's poor bone quality.

Event Description

On (b)(6) 2018 a patient underwent a 12-level lumbar fusion from t6 - s1.On (b)(6) 2019 the patient underwent a removal and revision surgery due to loose screws identified on a follow-up ct myelogram.The representative covering the case reported that the patient had "crazy poor" bone quality which contributed to the screws becoming loose more than nine months after the initial surgery.All genesys spine tilock hardware was removed and the surgeon placed a competitor's fenestrated screw system in order to inject pmma (bone cement) to help stabilize the new pedicle screws.Post-op the representative reported the patient was recovering well and as expected.

• 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 ; austin, TX 78746 ; 5123817071
• MDR Report Key: 8655881
• MDR Text Key: 146633394
• Report Number: 3008455034-2019-00004
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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 ATTACHED
• Device Lot Number: SEE ATTACHED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• 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