H6: investigation findings:4248.Investigation conclusion: 61.H10.This interbody was placed and saw post-operative collapse which resulted in a revision cage necessary.Following explanation, the implant was sent here for evaluation.Below is a list of the findings that i saw when analyzing the interbody: the running torque of the implant (expansion and collapse directions) was measured with torque meter and values between 0.50-0.80 in-oz were recorded across the length of the expansion distance.Per the p/n 320-xxxxxx00 drawing as stated on flag note 2 (shown below) a minimum of 4.5 in-oz is required of an in-specification interbody.This specification is on the qir and is 100% inspected on all incoming interbodies.The engineering team investigated damage to the interbody, specifically the expansion mechanism.The drive screw anti-collapse tines are intact and seem to be in good condition.There is graft material present, but this is expected.The drop in torsional resistance likely occurred after the interbody was placed in the non-sterile set caddy and then implantation of the device.Because the interbody appears to be structurally sound, then it is most likely that a relaxation of the drive screw tines occurred during this timeframe.The only manner in which the engineering team was able to replicate the drop of torsional resistance is the repeated motion of fully expanding and collapsing the interbody multiple times.Therefore, it seems most likely that this failure mode occurred prior to the implantation of the cage and stems from the potential repeated testing/demo of the interbody prior to use.Labeling review: "preoperative management: the condition of all implants and instruments should be checked prior to use.Damaged and/or worn implants and instruments should not be used." "possible adverse effects: possible adverse effects include: initial or delayed loosening, bending, dislocation, and/or breakage of device components.".
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