MAUDE Adverse Event Report: SYNTHES (USA) TI CLICK''X® LOCKING CAP FOR TI3-D HEAD

Catalog Number 498.570

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that the patient was originally treated for a burst fracture of t12 about 18 months ago, exact date unknown.The patient had the click x construct implanted due to this fracture.Upon reevaluation, the surgeon discovered that a pedicle screw broke just the below the head on the patients left l2 disk which was confirmed by x-ray on an unknown date.It was reported that patient was feeling discomfort from the hardware prominence.Due to the fact that the fracture had healed the surgeon choose to remove all the hardware and the explant was done on (b)(6) 2014 with no issues.The product has not been returned for investigation and no further information was provided.This is report 20 of 27 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Actual event date not known.Implant on unknown date - approx (b)(6) 2012, 18 months ago.Investigation could not be completed and no conclusion could be drawn as the device was not returned and no lot number was provided.Placeholder.

• Brand Name: TI CLICK''X® LOCKING CAP FOR TI3-D HEAD
• Manufacturer (Section D): SYNTHES (USA); west chester PA
• Manufacturer Contact: s. o''malley ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3594846
• MDR Text Key: 4066982
• Report Number: 2520274-2014-00172
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention