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

Model Number SEE EVALUATION SUMMARY

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

Patient Problem No Information (3190)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

Adjacent segment disease can occur for a number of reasons.The implants removed in this case performed to the requirements, however, the segment above the implants degenerated to the point where surgery was required to correct the condition.The surgeon performing the r&r removed all pedicle screw hardware and placed a new four-level construct.Device not returned to manufacturer.

Event Description

A revision surgery was performed due to adjacent level disease in the lumbar spine.Thirty three months after being treated for a three level lumbar fusion a removal and replacement surgery was performed due to progression of the lumbar degeneration at the adjacent level above the initial construct.The three levels treated in 2014 had fused successfully but the lumbar degeneration had progressed to the adjacent level above.The surgeon performing the r and r removed all pedicle screw hardware in order to put in a new four-level construct.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): GENESYS SPINE; 1250 capital of tx hwy south; building three, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE
• Manufacturer Contact: william sowers ; 1250 capital of tx hwy south; building three, suite 600; austin, TX 78746 ; 5123817080
• MDR Report Key: 6564163
• MDR Text Key: 75060297
• Report Number: 3008455034-2017-00002
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE EVALUATION SUMMARY
• Device Catalogue Number: SEE EVALUATION SUMMARY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 91