The associated complaint device was returned and evaluated.The lab analysis concluded, the purpose of this investigation was to examine the returned device.No destructive analysis was conducted.Due to the size of the plate, the fracture surface was unable to be evaluated using the sem.From the analyses conducted during this investigation, the exact cause of the reported failure was not able to be determined.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.If new information is received in the future, this complaint can be re-opened.
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