The device was not received for evaluation.No device identifiers; serial number, lot number, were provided therefore a review of the lot history records could not be performed.A review of the risk management file resulted in no new risk associated with the device.Rmf 0003 rev 36 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 36 line 12.20.- migration/loosening, acute requiring additional surgery, with explantation, involving patient with only a single level m6-c rmf 0003 rev 36 line 12.75 - device explanted.
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