MAUDE Adverse Event Report: ALPHATEC SPINE INC TRESTLE LUXE ANTERIOR PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 alphatec director of compliance & complaints supervisor spoke to the patient's husband.The husband provided information concerning her issue and indicated she was going in for x-rays that day & allergy testing the following week.He explained that her rash first started at the shoulder neck line but has moved down and expanded.The pain began two (2) weeks post op and has increased daily to the point that meds are required to help reduce the pain to a tolerable level.The surgeon explained to them that although it can happen, an allergic reaction is extremely rare.He believes the issue may be mechanical and related to non-fusion which is causing the plating system to loosen and is likely the source of the pain.The husband later notified alphatec via e-mail that according to the hospitals technician, x-rays of the device looked good.Alphatec provided material information to husband as requested.The e-mail contained information relevant to the materials from which the alphatec spine implants are manufactured.The trestle luxe anterior plating system implant are manufactured from surgical grade titanium alloy and nitinol which comply with both astm f136 & astm f2063 standards.Instructions for use (ins-048) state: the trestle luxe anterior cervical plating system is contraindicated for: patients with probable intolerances to titanium, titanium alloy or its components (such as aluminum, titanium, or vanadium).Patients with probable intolerances to nitinol or its components (such as chromium, cobalt, copper, nickel, niobium, or titanium).Additionally, alphatec informed the patient's husband that alphatec is a medical device manufacturer and cannot provide any medical advice.

Event Description

Patient's husband contact alphatec directly indicating his wife had a trestle luxe plate implanted approximately 6 weeks ago.He requested information about the composition of the trestle luxe plate and if there was any nickel in the plate system.His wife has a nickel allergy and so he was concerned.

• Brand Name: TRESTLE LUXE ANTERIOR PLATING SYSTEM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard welch ; 5818 el camino real; carlsbad, CA 92008 ; 7604946611
• MDR Report Key: 5966888
• MDR Text Key: 55263840
• Report Number: 2027467-2016-00072
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/31/2016

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?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other