MD-VUE LATERAL ACCESS SYSTEM

Additional Manufacturer Narrative

H3 DEVICE EVALUATION - EVALUATION OF THE RETURNED PRODUCT BY THE ORIGINAL MANUFACTURER NOTED THAT UPON INITIAL INSPECTION, BLACK RESIDUE WAS IDENTIFIED BETWEEN THE CENTRAL HOUSING AND THE KNOB. THIS TYPE OF RESIDUE TYPICALLY RESULTS FROM GREASE THAT HAS BEEN COMPROMISED DUE TO REPROCESSING OUTSIDE OF THE VALIDATED PARAMETERS. REVIEW OF DEVICE HISTORY RECORDS FOUND TEN (10) PIECES OF LOT 46995PS RELEASED FOR DISTRIBUTION ON 1/26/2024 WITH NO DEVIATION OR ANOMALIES. TWO-YEAR COMPLAINT HISTORY REVIEW (6.10.2023-2.10.2025) FOUND THIS TO BE THE ONLY COMPLAINT OF THIS NATURE FOR THE REPORTED PART NUMBER. ALTHOUGH THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED, IN AN EFFORT TO PREVENT RECURRENCE, AN EMAIL WAS SENT TO THE COMPLAINANT REVIEW OF CLEANING AND STERILIZATION REQUIREMENTS.

Description of Event or Problem

IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR ADJACENT LEVEL DISEASE ON (B)(6) 2025, UTILIZING THE MD-VUE LATERAL RETRACTOR. DURING ASSEMBLY OF THE NOVID TABLE ARM IT WAS NOTED THAT THERE WAS "BLACK GREASE" COMING FROM THE TURN WHEEL OF THE TABLE CLAMP IN THE CASE. THE LATERAL ACCESS PROCEDURE WAS ABORTED AND A TLIF PROCEDURE WAS THEN PERFORMED. THERE WAS A THREE-HOUR DELAY TO THE PROCEDURE AS A RESULT OF THESE ISSUES. NO PRECISION SPINE IMPLANTS WERE USED DURING THE INITIAL OR REVISION PROCEDURE. ALL IMPLANTS WERE COMPETITOR PRODUCTS.

Additional Manufacturer Narrative

H3 OTHER - EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR ADJACENT LEVEL DISEASE ON (B)(6) 2025, UTILIZING THE MD-VUE LATERAL RETRACTOR. DURING ASSEMBLY OF THE NOVID TABLE ARM IT WAS NOTED THAT THERE WAS "BLACK GREASE" COMING FROM THE TURN WHEEL OF THE TABLE CLAMP IN THE CASE. THE LATERAL ACCESS PROCEDURE WAS ABORTED AND A TLIF PROCEDURE WAS THEN PERFORMED. THERE WAS A THREE-HOUR DELAY TO THE PROCEDURE AS A RESULT OF THESE ISSUES. NO PRECISION SPINE IMPLANTS WERE USED DURING THE INITIAL OR REVISION PROCEDURE. ALL IMPLANTS WERE COMPETITOR PRODUCTS.