MAUDE Adverse Event Report: SYNTHES (USA) 6.2MM TI CLICK''X® PEDICLE SCR DUAL CORE 45MM THREAD LENGTH

Catalog Number 498.563

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); 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 below the head on the patient's 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 chose 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 6 of 27 for complaint (b)(4).

Manufacturer Narrative

Actual event date not known.Implant on unknown date - approx (b)(6) 2012.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: 6.2MM TI CLICK''X® PEDICLE SCR DUAL CORE 45MM THREAD LENGTH
• 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: 3594605
• MDR Text Key: 4069346
• Report Number: 2520274-2014-00157
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 01/28/2014
• 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