While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Returned product was one palodent v3 ring universal.The ring returned was broken in half at the pivot point (center) with overmolding identifications as "i." for 2019 and "f" for june.Per the useful life of the device at 2 years from date of manufacture the complaint is considered not substantiated as the ifu states automated disinfection up to 500x and sterilization process up to 1000x, which is equivalent to 2 years of use.
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