MAUDE Adverse Event Report: ALPHATEC SPINE INC 4.0 VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14MM (TI-6AL-4V ELI); KWQ

Model Number 71340-14

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible.The screw has not been removed from the patient nor has the identifying lot number been provided.Both the surgical technique (lit-84315) and instructions for use (ins-048) state; the surgeon must take great care to properly position bone screw holes when using the variable drill guide and self centering awl.Excessively converging hole patterns may prohibit proper seating of the bone screws.Hole patterns angled beyond 9° may prohibit proper seating.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 (astm f136) and nitinol (astm f2063) and the bone screws are manufactured from surgical grade titanium alloy (astm f136).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.Upon the receipt of additional information and/or revision surgery, a follow-up report will be submitted.

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 c5 vertebrae.No plans to remove the screw at this time.

• Brand Name: 4.0 VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14MM (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: 4949538
• MDR Text Key: 23125023
• Report Number: 2027467-2015-00121
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 71340-14
• Device Catalogue Number: 71340-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR