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 04/30/2019

Event Type  Injury  

Event Description

A trauma patient had hardware placed to restrict motion and stabilize a 2-level fracture from t10 - t12 on (b)(6) 2018.Nearly a year after the initial surgery, the patient underwent a removal surgery as the fracture had healed.No other hardware was placed at the time of the removal and all genesys spine hardware was removed intact.

• 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: 8605193
• MDR Text Key: 144872286
• Report Number: 3008455034-2019-00005
• 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: 05/08/2019

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 EVALUATION SUMMARY
• Device Lot Number: SEE EVALUATION SUMMARY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• 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): Other