Complaint 1 of 2.Visual inspection of the returned device revealed that the rod had been partially distracted.X-ray images of the internal components showed no damage, and confirm the rod was partially distracted.Additionally, x-ray images of the internal components revealed that the threaded cap was seated properly between the distraction rod and the housing tube.No issue was observed with the end cap.The rod was functionally tested; during testing the rod was able to be distracted and retracted with the external remote controller (erc) as well as with the manual distractor.The length as received was measured at 310.54 mm.The minimum and maximum lengths were measured at 309.80 mm and 357.10 mm respectively; giving a total stroke measurement of 47.30 mm, which meet the specification.Distraction force testing was measured at 45.20lbs, which meets specification.Reported failure event cannot be duplicated or confirmed.A review of the dhr documents indicated that the rod has been manufactured by the specified requirements at that time and met all of the required quality inspections before shipment.
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