It was reported through the product team that a sales rep has reported a possible patient reaction incident involving an arthrex volar plate.The material composition information was provided to the sales rep, for the surgeon, by the product team.Additional information provided 6/1/2020: the patient had undergone a distal radius fracture orif procedure on (b)(6) 2020.The patient had the initial post op visit on (b)(6) 2020 at which time the patient was taken to the or for and irrigation and debridement for a presumed infection.Cultures has all been negative: negative aerobic, anaerobic, fungal and afb.Symptoms of drainage, blistering, rashes and wound healing issues have all been assessed by the surgeon, infectious disease and dermatology.Patient has been treated to date with steroids and antibiotics (topical and oral).It is unknown if patient has been tested for specific known allergies however it has been reported that patient has developed allergic reaction to almost everything (adhesive, suture, prep, multiple antibiotics).The patient has an allergist visit scheduled for (b)(6) 2020.The following are the arthrex devices that were implanted during the (b)(6) 2020 procedure: ar-8916vnr-03, volar drp nrw rt 3 hole, lot 10299223.Ar-8935-16, lo-pro screw, 3.5x16mm, lot 10412931.Ar-8935-14, lo-pro screw, 3.5x14mm, lot 10229247.Ar-8935-14, lo-pro screw, 3.5x14mm, lot 10294237.Ar-8916cx24-22, low profile screw, 2.4mm x 22mm cortex, lot 171745.Ar-8724v-16, 2.4 x 16mm val screw, ti, lot w6677819 (qty 4).Ar-8724v-18, 2.4 x 18mm val screw, ti, lot w698661 (qty 2).Ar-8935l-14, locking screw, titanium 3.5mm x 14mm, lot 10251644.Ar-8935l-16, locking screw, titanium 3.5mm x 16mm, lot 10395918.
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