MAUDE Adverse Event Report: ALPHATEC SPINE INC TRESTLE SCREW; KWQ

Device Problem Device Slipped (1584)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/14/2015

Event Type  Injury  

Event Description

An international customer ((b)(6)) reported that on (b)(6) 2015 a patient returned to the surgeon due to a weird feeling in the throat.The surgeon found that one of the trestle screws had backed out from the plate and was located in the patients throat.Revision surgery was conducted at a separate hospital where the screw was removed.The trestle anterior cervical plating system was originally implanted on (b)(6) 2010.

Manufacturer Narrative

An evaluation cannot be conducted.The suspect device has not been returned nor has the identifying part or lot numbers been provided.Multiple attempts to obtain additional information have been unsuccessful.Upon the receipt of additional information and/or the return of the suspect device a follow up report will be submitted.The trestle anterior cervical plating system is a temporary device used to stabilize the cervical spine during bone fusion development.It is intended for use in the anterior cervical spine (c2-c7).A primary feature of the trestle plating system is the proprietary zero step self-locking mechanism.While advancing the screw, the blocking slide will move medially.When the screw is fully inserted and the screwdriver removed, the blocking slide will return to the center position.Both the surgical technique and instruction for use ((b)(4)) 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 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: TRESTLE SCREW
• 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: 4714164
• MDR Text Key: 5665712
• Report Number: 2027467-2015-00065
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K102820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR