MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 014MM (TI-6AL-4V ELI, NITINOL); KWQ

Model Number 71001-014

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

Review of the device history records revealed no manufacturing, processing or design related irregularities.The trestle luxe plate was found to be properly manufactured and released in accordance with the device master record.An evaluation of the trestle luxe plate is not possible at this time.The implant has not been returned.Upon the return of the suspect device and/or additional information, 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 (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.

Event Description

An international customer ((b)(6)) reported that while trying to lock the trestle luxe screws into the plate, the plates gold locking mechanism became detached.All four (4) screws and plate were removed and replaced causing over a 30 minute delay in the case.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 014MM (TI-6AL-4V ELI, NITINOL)
• 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: 5049710
• MDR Text Key: 24877607
• Report Number: 2027467-2015-00176
• 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: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 71001-014
• Device Catalogue Number: 71001-014
• Device Lot Number: 691165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR