MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 030 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71002-030
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible.The device has not been returned for evaluation nor has the identifying lot number been provided.No additional information is known or has been furnished at this time.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 or Problem Description
A patient called atec directly indicating a trestle plate was broken and additional surgery was conducted.Revision surgery took place on (b)(6) 2019 with the same surgeon and at the same hospital.The trestle luxe anterior plating system was originally implanted on (b)(6) 2014.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 030 MM (TI-6AI-4V ELI, NITINOL)
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8586635
• Report Number: 2027467-2019-00023
• Device Sequence Number: 16560847
• Product Code: KWQ
• UDI-Device Identifier: 00844856066991
• UDI-Public: (01)00844856066991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71002-030
• Device Catalogue Number: 71002-030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR