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

Model Number G150-70

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

Patient Problem Failure of Implant (1924)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

During a pt post op visit, 1 month after the surgery, x-rays revealed that one of the rods in the construct had slipped from the tulip of the screw.The surgeon is monitoring the pt and at this point has chosen not to perform revision surgery due to the fact that fusion is occurring successfully.The pt is not in pain or discomfort.

Manufacturer Narrative

No product has been returned for review and eval of this implant.Three is no connection that can be made between the event and any shortcoming of the device at this time.Root cause has not been identified but it appears that the rod size selected for the construct was too short.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): GENESYS SPINE; austin TX
• Manufacturer Contact: dave lamb ; 1250 s capital of tx highway; building three, suite 600; austin, TX 78746 ; 5123817094
• MDR Report Key: 4196577
• MDR Text Key: 19768875
• Report Number: 3008455034-2014-00008
• Device Sequence Number: 1
• Product Code: MNH
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G150-70
• Device Lot Number: 11210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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: 7.5MM PEDICLE SCREWS; SET CAPS