It was reported that a piece of the hook broke off, of the patient's custom made tap appliance.The incident occurred in the middle of the night, while in the patient's mouth.The exact date of event was not available, it happened sometime between (b)(6) 2017.The patient reported the piece of hook was swallowed.The doctor's office reported that there was no clinical intervention required and no report of injury.The device will not be returned at this time, but a remake of the device was requested.
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The device will not been returned.However, photos were provided for a visual investigation and the results are as follows: device history record: no dhr was available for review since the device was fabricated per physician's prescription only.Stock product results: no stock product was available for review sine the device was fabricated per physician's prescription only.Returned sample: patient did not return the device for investigation but two photo of patient's appliance (upper/lower) was provided by the physician.The patient complained the hook broke off on the lower tray, which was made out of hardware components (front plate, two locking screws, base plate, a hook and adjustment screw).The quality associate from our hardware supplier, airway management, reviewed both upper/lower pictures and confirmed all hardware components were in place, and it did not appear that the hook was missing.Glidewell production reviewed the photos and also confirmed that the hardware components, appeared to be in place.However, in the photograph provided, it appear that part of the lower tray's acrylic parts have separated along with the portion that contains the components, and both the upper and lower trays show signs of wear.The thermoforming production group pulled an intact appliance and compared it with the photo of the patient's appliance.It was confirmed that the hook appears to be intact and not missing.Both locking screws were in original shape and in place.Airway management reviewed and supported this observation.
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