MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI NARROW LT 3H; PLATE, FIXATION, BONE

Model Number VOLAR DISTAL RAD PLT TI NARROW LT 3H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the patient began experiencing severe eczema on the back of their neck shortly after having ar-8916vnl-03 volar distal radius plate implanted.Eczema is unresponsive to all treatment.The physician will be testing for heavy metal sensitivity to determine if there is any correlation to the implant.Additional information obtained 10/14/2020: the date of the patient's implant surgery was (b)(6) 2018.Patient symptoms since implant have been eczema, severe gluten intolerance and leaky gut syndrome.Symptoms began approximately 4 weeks post surgery.To date patient has been treated with a gluten free diet, enzyme and supplement therapy.No cultures have been taken.At this time no second surgery is planned.

• Brand Name: VOLAR DISTAL RAD PLT TI NARROW LT 3H
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10698288
• MDR Text Key: 211952046
• Report Number: 1220246-2020-02236
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867130852
• UDI-Public: 00888867130852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VOLAR DISTAL RAD PLT TI NARROW LT 3H
• Device Catalogue Number: AR-8916VNL-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other