Roi-c : conflict anchoring plate with caspar pins.From information provided, during a roi-c surgery, the anchoring plate and the cage must have been removed because there was a conflict between caspar pin and anchoring plate.It is due to surgeon has not removed caspar pins during implantation of anchoring plate.No harm on patient.No delay more than 30 minutes on surgery.
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Correction: a1, b5, d1, d2 (common device name), e1, e2, e3, g3, h1, and h6 (method and results).Additional information: d4 (udi number), g5 (pma/510(k) number), h6 (device and conclusions).D10 - the product was returned to the manufacturer for evaluation; however, the exact date of return is unknown.The returned plate was evaluated.Visual inspection found that the tip of the device is bent.A review of the manufacturing records found no nonconformances or temporary deviations that would have contributed to this failure and the device was likely conforming when it left zimmer biomet's control.The labeling was reviewed and found to contain instructions regarding proper device usage.In the reported incident, the surgeon did not remove the caspar pin prior to installing the anchoring plate.Per the surgical technique guide, it is advised to remove the pins if they have not been placed properly as they can impede anchoring plate preparation and insertion.In this event, the bent anchoring plate was likely caused by the caspar pin being in the trajectory of the anchoring plate.This metal-on-metal contact caused the plate to bend.
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