MAUDE Adverse Event Report: GENESYS SPINE TILOCK PEDICLE SCREW SYSTEM; LOCKING CAP

Model Number G826

Device Problems Misassembled (1398); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/15/2014

Event Type  Injury  

Event Description

Five days post implantation the patient came in to visit the doctor complaining of pain and discomfort.Upon xray examination, the surgeon noticed one rod in the l5-s1 construct had slipped out of one of the pedicle screws.The need for revision surgery was explained to the patient and revision surgery was performed on that day.The patient is recovering well at this time.This is the first occurrence of rod slippage reported on this or any genesys spine product.It appears that too short a rod was used when building the pedicle screw construct and there was not adequate purchase on the rod.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: LOCKING CAP
• Manufacturer (Section D): GENESYS SPINE; austin TX
• Manufacturer Contact: dave lamb ; 1250 capital of tx hwy south; building three, suite 600; austin, TX 78746 ; 5123897094
• MDR Report Key: 4066308
• MDR Text Key: 4731638
• Report Number: 3008455034-2014-00003
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• 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: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G826
• Device Lot Number: 11631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: 60MM ROD; IMPLANTED:
• Patient Outcome(s): Required Intervention