MAUDE Adverse Event Report: ALPHATEC SPINE INC 4.5MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 12MM (TI-6AL-4V ELI); KWQ

Model Number 71345-12

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

While inserting a two-level anterior plate on (b)(6) 2015 a self tapping screw passed completely thru plate into the patient's vertebral body.The screw remains seated beneath the plates locking mechanism entrapped within the patients c7 vertebrae.The trestle luxe construct consists of a 034mm plate and four self tapping screws which continues to be properly positioned at the c5-c7.

Manufacturer Narrative

No evaluation possible.The suspect implant has not been removed from the patient.A review of the device history records indicated the luxe screw was properly manufactured and released according to design specifications.No irregularities have been identified.Upon the receipt of additional information and/or revision surgery, a follow-up report will be submitted.The trestle luxe anterior cervical plating system is a temporary device used to stabilize the cervical spine during bone fusion development.Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted.Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws.Implant plates are manufactured from surgical grade titanium alloy ((b)(4)) and nitinol ((b)(4)) and the bone screws are manufactured from surgical grade titanium alloy ((b)(4)).All device components are intended for fixation/attachment to the anterior cervical spine only.It is intended that the implants be removed after successful fusion.

• Brand Name: 4.5MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 12MM (TI-6AL-4V ELI)
• Type of Device: KWQ
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 4510555
• MDR Text Key: 5439244
• Report Number: 2027467-2015-00001
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K102820
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 71345-12
• Device Catalogue Number: 71345-12
• Device Lot Number: 674746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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