MAUDE Adverse Event Report: CTL MEDICAL CORPORATION TAURUS; Orthosis, spinal pedicle fixation

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Patient presented with a skin rash/legion at the surgical site.Surgeon speculation was that the patient reacted to implant material.This incidient was then reported to ctl but the parts were not returned for evaluation.We are submitting this submission as a summary submission as parts were not identified nor returned for further identification.It is not known whether the speculation is correct without further information.Universally, risk due to patient's hypersensitivity reactions to titanium alloys are very rare, and the vast majority of people with titanium implants do not experience any adverse reactions.Confirmation and treatment should be a collaborative effort between various healthcare professionals, based on the symptoms and the patient's medical history.Ctl has reviewed and assessed this incident.As per astm f136 titanium alloys are considered to be among the most biocompatible metals.They are used extensively in medical applications, such as orthopedic joint replacements, dental implants, and surgical instruments, among others.Allergic reactions to titanium are extremely rare.Most literature suggests that titanium is non-allergenic and does not cause reactions in the vast majority of individuals.The immune response to titanium is typically negligible, and it's generally well-tolerated by the human body.However, there have been occasional reports of hypersensitivity reactions to titanium, though these are very rare.Cause indeterminate and requires hypersensitivey confirmation.

• Brand Name: TAURUS
• Type of Device: Orthosis, spinal pedicle fixation
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel parkway; addison TX 75001
• Manufacturer (Section G): CTL MEDICAL CORPORATION; 4550 excel parkway; addison TX 75001
• Manufacturer Contact: tracy bui ; 4550 excel parkway; addison
• MDR Report Key: 16967672
• MDR Text Key: 315964775
• Report Number: 3009051471-2023-00013
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1