OBSIDIAN BLOCK A2 MILLING BLOCKS

Additional Manufacturer Narrative

A NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: NO DHR RESULTS AS NO LOT NUMBER WAS PROVIDED. STOCK PRODUCT REVIEWED RESULTS: NO STOCK PRODUCT REVIEW RESULTS AS NO LOT NUMBER WERE PROVIDED. INVESTIGATION METHODS/RESULTS: CUSTOMER HAS NOT RETURNED THE COMPLAINT PART FOR INVESTIGATION TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. THE PROBABLE ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO HOW THE PATIENT USED THE RESTORATION SUCH AS POTENTIALLY BITING DOWN A HARD OBJECT WHICH CAN CAUSE A RESTORATION TO FRACTURE. IT IS UNKNOWN THE PATIENT'S MEDICAL HISTORY, BUT BRUXISM CAN ALSO CAUSE THE RESTORATION FRACTURE OVER TIME DUE TO THE EXCESSIVE PRESSURE AND GRINDING ON THE RESTORATION WHICH CAN LEAD TO THE DECREASE IN STRENGTH OF THE RESTORATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

CORRECTED: H11. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). THIS IS THE SECOND OF THREE COMPLAINTS RELATED TO MDR NUMBERS: 3011649314-2024-00846, 3011649314-2024-00848.

Additional Manufacturer Narrative

THE DEVICE SKU/CATALOG NUMBER NOR THE LOT NUMBER OF THE DEVICE WAS AVAILABLE FOR THE REPORTED COMPLAINT. THE CUSTOMER REPORTED THAT THIS INFORMATION IS NOT KNOWN AND THAT THE PATIENT KEPT THE DEVICE AND "AFTER SO MUCH TIME PASSED, I DO NOT THINK THE PATIENT'S KEPT THEM". THEREFORE, A REVIEW OF THE DEVICE LOT HISTORY RECORDS COULD NOT BE CONDUCTED AT THIS TIME. IMAGES OF THE DEVICE WERE PROVIDED AND WILL BE REVIEWED. AT THE COMPLETION OF OUR INVESTIGATION, A FINAL REPORT WILL BE PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). THIS IS THE FIRST OF THREE COMPLAINTS FOR THE SAME PATIENT, RELATED MDR NUMBERS: 3011649314-2024-00846. 3011649314-2024-00848. CAPA: CA-00016

Description of Event or Problem

OFFICE REPORTED THAT AN OBSIDIAN CROWN HE MILLED FOR A PATIENT FOR TOOTH #22, HAS BROKEN IN THEIR MOUTH AND WOULD LIKE A REPLACEMENT. THE DOCTOR RE-MILLED AND SEATED A NEW CROWN. THERE WAS NO REPORT OF AN ADVERSE CONSEQUENCE.