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

Model Number TILOCK

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

This report was initiated upon request for instrumentation to remove a previously implanted device manufactured by genesys spine.The original surgeon was not involved in the removal.No info regarding the condition of the explanted device was obtained from removal surgeon.Patient took possession of explanted device.Representative from hospital confirms patient is recovering well.No further info is available at this time.

Event Description

Patient underwent removal procedure for a pedicle screw construct.Patient with fixation at l4-l5 complained of pain and saw a different physician than originally performed procedure.Post op follow up physician offered removal as a remedy for the pain.Removal of construct was completed successfully by follow up surgeon.Patient is recovering well.

• Brand Name: SPINAL FIXATION SYSTEM
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): GENESYS SPINE; 1250 s capital of tx highway; building 3, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE; 1250 s capital of tx highway; building 3, suite 600; austin TX 78746 0000
• Manufacturer Contact: dave lamb ; 1250 s capital of tx highway; building 3, suite 600; austin, TX 78746 ; 5123817094
• MDR Report Key: 5266876
• MDR Text Key: 32705503
• Report Number: 3008455034-2015-00012
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/01/2015

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: TILOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 12/01/2015
• 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): Hospitalization