Description of Event or Problem · 0
1. DESCRIPTION: I DON¿T THINK ANY ACTIONS ARE INTENTIONAL. I BELIEVE THEM TO BE DUE TO A MANAGEMENT TEAM WITHOUT SUFFICIENT MEDICAL DEVICE EXPERIENCE. ¿ RECEIVED 510K CLEARANCE FOR CUSTOM CERAMIC DEVICE, BUT POSSIBLY MODIFYING THE DEVICE AFTER RECEIVING CLEARANCE TO TEST NEW PRODUCT FEATURES ON PATIENTS, WHICH MAY EXCEED SCOPE OF CLEARANCE ¿ POSSIBLE USE OF A CUSTOM METAL DEVICE ON A PATIENT BEFORE RECEIVING 510K CLEARANCE ¿ POSSIBLE PROMOTION OR ADVERTISING OF A DEVICE OUTSIDE THE FDA-CLEARED OR APPROVED INDICATIONS FOR USE ¿ POSSIBLE UNREPORTED ENAMEL DAMAGE THAT MEETS THRESHOLD FOR SERIOUS INJURY ¿ POSSIBLE MEDICAL DEVICES OR MANUFACTURING PROCESSES THAT DO NOT MEET THE COMPANY¿S DESIGN AND MANUFACTURING RESPONSIBILITIES, INCLUDING EITHER INSUFFICIENT QMS (FOR EXAMPLE, LACK OF ADEQUATE DESIGN CONTROL) OR FAILURE TO COMPLY WITH ITS QMS (UNAPPROVED SUPPLIERS), THUS LEADING TO PRODUCT QUALITY ISSUES (EVEN IF PATIENT SAFETY IS NOT COMPROMISED, THE COMPANY APPEARS UNABLE TO MEET PRODUCT SPECIFICATION REQUIREMENTS (FOR EXAMPLE, RELATED TO SLOT DIMENSIONS (ACCURACY AND TOLERANCES). REFERENCE REPORT: MW5161849.