PRISMATIK DENTALCRAFT, INC. ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE, PRODUCT CODE: LRK; EMA
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Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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This incident is currently under investigation; once completed, a supplemental report will be submitted.As of the time of this report, the reported device had not yet been received, and we are unclear if it will be provided.Further follow-up is being conducted.
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Event Description
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It was reported that a night guard broke during the middle of the night.The patient was awakened by a loud pop and a sharp point in the left side of her cheek.It was determined that the top piece of the snore guard had snapped into 2 pieces right behind her eye tooth (canine tooth).Patient was thankful that she did not swallow the broken piece.Additional information received, the patient did not suffer any adverse event nor serious injury, just felt like she may of had a small cut on the inside of the left cheek that resolved right away.The appliance was checked back (b)(6) 2017 when she went to the doctor's office for her cleaning.She stated that the doctor said it was in good condition.The incident occurred the night of the (b)(6) october.Further clarification was received that the mandibular section broke in ½, no photos and unsure if the device is available for return.
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