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
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10698288
• Report Number: 1220246-2020-02236
• Device Sequence Number: 3058376
• Product Code: HRS
• UDI-Device Identifier: 00888867130852
• UDI-Public: 00888867130852
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other