MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON TAS BONE SCREW

Catalog Number 2300-5530

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

This is a retro-spective complaint review- the endoskeleton tas bone screw 2300-5530 (v13) is jammed through the endoskeleton tas implant cage window, 2312-0112-n((b)(4)).The bone screw is unable to be separated from the implant with use of normal instrumentation.The bone screw contained damaged threading which likely resulted from the bone screw incorrectly being inserted through the implants cage window.The bone screw's hex has damage and appears to be stripped.This damage could have been caused by the screw being incorrectly forced into position or while attempting to back the screw out.The implant has damage at the bone screw insertion holes and the implants cage window, the implant has been deformed in these areas reasonably caused by a bone screw being forced into an incorrect position.Endoskeleton tas surgical technique provides instructions for the proper placement of bone screws with tas implants.X-rays should be used to confirm the desired trajectories of the bone screws.If surgeon used x-rays to confirm trajectory of the bone screw in this case, surgeon would have been able to identify the incorrect trajectory of the bone screw prior to driving the screw into the jammed position within the implant.A review of the dhr was performed, the review revealed there were no anomalies or non-conformances generated during the manufacture of these devices that would attribute to this complaint.The device was found to be within specification during final inspection.

Event Description

During a scoli deformity correction the surgeon was doing an alif l4/l5 procedure, somehow drove the screw through the back of the implant and were not able to back the screw out.The surgeon attempted to back out the cage with the screw in place.During the process something vascular was nicked, the vascular surgeon clamped the vessel and was able to stop the bleeding.Surgeon was able to put in another cage and complete the procedure.The vascular surgeon closed the patient and the surgery was completed.

• Brand Name: ENDOSKELETON TAS BONE SCREW
• Type of Device: BONE SCREW
• Manufacturer (Section D): TITAN SPINE; 6140 w executive dr; ste a; mequon WI 53092
• Manufacturer Contact: jane rodd ; 6140 w executive dr. ste a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 7275002
• MDR Text Key: 100235211
• Report Number: 3006340236-2018-00004
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2300-5530
• Device Lot Number: V13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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): Other