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

Model Number TILOCK REDUCTION

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

Patient Problems Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The operative report for the initial procedure on (b)(6) 2014 reported several complications although none were associated with the genesys spine hardware.As a result of these complications and/or surgeon preference a full pedicle screw construct was not placed.A unilateral construct (half the normal construct) was placed and this construct only covered one of the two levels treated.More than two years after the initial procedure the patient was scheduled for removal of the original hardware (including genesys spine hardware and other competitor's hardware), treatment of the adjacent level of the lumbar spine, and installation of new hardware.When the genesys spine hardware was removed, it was reported to be intact although the hardware was not returned for formal inspection.A review of all associated manufacturing records for the genesys spine products showed no anomalies and no possible signs of any issues.Devices not returned.

Event Description

Revision surgery was preformed due to adjacent level disease in the lumbar spine.Patient was originally underwent a two-level lumbar fusion procedure in (b)(6) 2014 and now has adjacent level disease.Removal and revision surgery was performed by a new surgeon.During the revision all hardware was found to be intact - there was no product malfunction.Following the procedure the surgeon reported the patient is recovering well on a normal regimen.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Type of Device: SPINAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): GENESYS SPINE; 1250 capital of texas hwy s; bld 3, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE; 1250 capital of tx hwy s; bld three, suite 600; austin TX 78746
• Manufacturer Contact: william sowers ; 1250 capital of tx hwy s; bld three, suite 600; austin 78746 ; 5123817080
• MDR Report Key: 6391031
• MDR Text Key: 69483678
• Report Number: 3008455034-2017-00001
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/07/2017

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: Physician
• Device Model Number: TILOCK REDUCTION
• Device Catalogue Number: G711-55-45 & G711-45-40
• Device Lot Number: 1044 & 1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2011
• 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
• Treatment: EXACTECH ELEVATED 6 - 10MM CAGE; OSTEOMED 12-MM PRIMALOK INTERSPINAL FIXATION DEVIC; TILOCK ROD AND SET CAP
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 91