CAMOUFLAGE NOW MILLING BLOCKS; GD-MANDREL; A2 LT; 14 (5 UNITS)

Additional Manufacturer Narrative

THE WAS RETURNED FOR ANALYSIS. AN INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR CAMOUFLAGE NOW LOT# 6263994 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. STOCK PRODUCT REVIEWED RESULTS: A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR CAMOUFLAGE NOW LOT# 6263994 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: 2 RESTORATIONS WERE RETURNED IN THE ORIGINAL PACKAGING. ONE RESTORATION WAS RETURNED FOR (B)(4) AND THE OTHER RESTORATION WAS RETURNED FOR (B)(4). IT WAS OBSERVED THAT THE 2 RESTORATIONS WERE FRACTURED. ROOT CAUSE: THE PROBABLE ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO THE MILLING CONDITION OF HAVING A POOR DESIGN OF THE RESTORATION. IT IS POSSIBLE THAT THE CUSTOMER PROVIDED AN INADEQUATE DESIGN WHICH CAN CAUSE RESTORATION TO NOT HAVE THE REQUIRED WALL THICKNESS. BY NOT MEETING THE REQUIRED WALL THICKNESS, THIS CAN CAUSE THE RESTORATION TO FRACTURE DURING THE PLACEMENT OF THE RESTORATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). CORRECTIONS: H6: UPDATED "TYPE OF INVESTIGATION" CODE. H6: UPDATED "INVESTIGATION FINDINGS" CODE. H6: UPDATED "INVESTIGATION CONCLUSIONS" CODE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR ANALYSIS. HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

Description of Event or Problem

OFFICE STATED THAT A CAMOUFLAGE CROWN CRACKED AFTER THE PATIENT BIT DOWN ON COTTON WHILE SEATING. IN A FOLLOW UP WITH THE CUSTOMER IT WAS REPORTED THAT THE CROWN CRACKED IMMEDIATELY AFTER BEING SEATED ON TOOTH #18 WHEN THE PATIENT BIT DOWN. A NEW CAMOUFLAGE CROWN WAS MILLED AND SEATED SUCCESSFULLY.