MAUDE Adverse Event Report: GENESYS SPINE TILOCK PEDICLE SCREW SYSTEM

Catalog Number G350-5-35

Device Problem Break (1069)

Patient Problem Implant Pain (4561)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that a tilock rod was found to be broken during post-op imaging almost four years after initial implantation.The patient underwent a removal/revision surgery to replace the broken device.No other complications were reported.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx hwy; bldg 3, ste 600; austin TX 78746
• Manufacturer Contact: chloe lance ; 1250 s. capital of tx hwy; bldg 3, ste 600; austin, TX 78746 ; 5123817089
• MDR Report Key: 15374508
• MDR Text Key: 305458575
• Report Number: 3008455034-2022-00011
• 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: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G350-5-35
• Device Lot Number: WT20180216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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: 57 YR
• Patient Sex: Male