MAUDE Adverse Event Report: ARTHREX INC. PLT ,TIB A/P SLPD OSTEO; PLATE, FIXATION, BONE

Catalog Number	AR-13200ST-07.5
Health Effect - Clinical Codes	Urticaria (2278); Inadequate Pain Relief (2388); Reaction (2414)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Lot number was not provided so device history record review cannot be performed.The contribution of the device to the reported event could not be determined as the device remained in the patient therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Other manufacturer's devices were also used in the initial surgery which may have also contributed to the patient's reaction.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported, that patient had a tibial osteotomy plate procedure on (b)(6) 2017.After the initial procedure, the patient started having an allergic reaction between two - two and half months after.Patient experienced hives all over the body.Patient then reached out to the surgeon who performed the procedure.On (b)(6) 2017, patient had a consultation with the surgeon, which prescribed antibiotic because it appear to be an infection.The antibiotics didn't work so surgeon suggested for the patient to see a dermatology specialist.The patient then saw a dermatology specialist at the university (b)(6); where the patient was tested for a staph infection.The biopsy results came back negative.Approximately the second or third week in (b)(6), patient saw another dermatology specialist.The dermatologist prescribed some cream to apply on the body.Patient described that the cream prescribed helps at times but is still having a reaction and hives will not go away.The patient has indicated that a staple and two screws from two other manufacturers were also implanted in the knee during the initial procedure.

• Brand Name: PLT ,TIB A/P SLPD OSTEO
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6740960
• Report Number: 1220246-2017-00286
• Device Sequence Number: 531889
• Product Code: HRS
• UDI-Device Identifier: 00888867009622
• UDI-Public: 00888867009622
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: AR-13200ST-07.5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2017
• 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: Other