(b)(4).On (b)(6) 2018 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
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Via phone conversation: jaw has broken.Additional information received via email on (b)(6) 2018: the date of use was actually 2 different dates.One was on tuesday (b)(6) 2018, and the other on (b)(6) 2018.The kerrisons did break while we were using them in patient¿s necks.There was luckily no harm to the patient or the doctor.Both of the kerrisons that we recently ordered have broken.Lot numbers- c17xme and l17xme.(b)(6) 2018 additional information: patient information: (age, gender, weight) one male, (b)(6), bmi (b)(6).One female, (b)(6), bmi (b)(6).Was there any patient medical intervention? no.What was the patient¿s medical status after the event? stable.Did any part of the device break/fall into the patient¿s body field? yes, the broken piece of the jaw fell into the neck.If yes how was the object retrieved? with the suction and forceps.Did the patient require an additional medical procedure such as an x-ray? no.How was the event resolved, was the device removed from use and replaced with another? kerrisons were removed from our sets, and now we have two sets down that are incomplete.What type of procedure was being performed? they were both acdf's.Was the procedure completed as planned? yes.Has your facility reported the event to the fda? no.No further information available.
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