PRODISC L INFERIOR END PLATE

Description of Event or Problem

A PATIENT WAS IMPLANTED WITH A PRODISC L IMPLANT ON (B)(6) 2026. FOLLOWING THE IMPLANTATION SURGERY, THE IMPLANT WAS FOUND TO HAVE EXPULSED ANTERIORLY WITH THE INLAY FULLY OUT OF THE DISC SPACE. IT WAS REPORTED THAT THE PATIENT HAD NO COMPLICATIONS OR SYMPTOMS, HOWEVER THE SURGEON MADE THE DECISION TO REMOVE THE IMPLANT AND FUSE THE PATIENT. THE REMOVAL SURGERY OCCURRED ON (B)(6) 2026. BOTH SURGERIES TOOK PLACE IN FRANCE.

Additional Manufacturer Narrative

AN MDR IS INDICATED FOR THIS COMPLAINT. IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PRODISC L IMPLANT ON (B)(6) 2026. FOLLOWING THE IMPLANTATION SURGERY, THE IMPLANT WAS FOUND TO HAVE EXPULSED ANTERIORLY WITH THE INLAY FULLY OUT OF THE DISC SPACE. IT WAS REPORTED THAT THE PATIENT HAD NO COMPLICATIONS OR SYMPTOMS, HOWEVER THE SURGEON MADE THE DECISION TO REMOVE THE IMPLANT AND FUSE THE PATIENT. THE REMOVAL SURGERY OCCURRED ON (B)(6) 2026. A DHR REVIEW COULD NOT BE COMPLETED AS THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED AND COULD NOT BE DETERMINED DURING THE COURSE OF THE INVESTIGATION. COMPLAINT TRENDING FOUND THAT THE RATE OF COMPLAINTS IS WITHIN THE LEVEL OUTLINED IN THE RISK DOCUMENTATION. A REVIEW OF THE RISK DOCUMENTATION FOUND THAT THE HAZARDS ASSOCIATED WITH THE COMPLAINT ARE IDENTIFIED AND MITIGATED TO A LEVEL WHERE THE CLINICAL BENEFITS OUTWEIGH THE HARMS. THE IMPLANT WAS NOT RETURNED FOLLOWING THE REMOVAL SURGERY THEREFORE NO EVALUATION COULD BE COMPLETED. IMAGING WAS PROVIDED THAT SHOWED THE MIGRATED ANTERIOR ENDPLATE. THERE WERE NO ANOMALIES IDENTIFIED DURING THE COMPLAINT INVESTIGATION. THE REMOVAL WAS COMPLETED DUE TO IMPLANT ENDPLATE MIGRATION. THIS REPORT IS FOR 3 OF 3 DEVICES INVOLVED IN THIS EVENT.