Integra has completed their internal investigation on may 15, 2017.Results: product was not received for inspection, however, a corrective action has been issued to investigate this reported failure (skull clamp helicoils coming off during pressure testing).Dhr review; no abnormalities relate to reported incident found nor where there any variances, mrr¿s or reworks associated with this work order# and lot#.No service history is on file for this device.Complaints history; a corrective action has been issued to further investigate this reported failure and as such will include the occurrence.Conclusion: the device in question was not received for evaluation therefore the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.
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