ROI-C SHORT ANCHORING PLATE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACDF PROCEDURE AT C5/C6 USING AN ROI-C IMPLANT. APPROXIMATELY 2.5 MONTHS POST-OPERATIVELY, A REVISION SURGERY WAS PERFORMED WHERE THE CAUDAL ANCHORING PLATE WAS OBSERVED TO HAVE BACKED OUT/DISLODGED FROM THE IMPLANT AND WAS REMOVED. BASED ON THE SURGEON'S CLINICAL JUDGMENT, NO ADDITIONAL IMPLANT OR CORRECTIVE PROCEDURE WAS PERFORMED, AND THE SURGERY WAS CONCLUDED AFTER REMOVAL OF THE PLATE.

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.