Description of Event or Problem · 0
DEVICES PROVIDED BY THE COMPANY FOR PREOPERATIVE SURGICAL PLANNING ARE DANGEROUSLY INACCURATE DUE TO A COMPLETE LACK OF VALIDATED QUALITY CONTROL AND REGULATORY COMPLIANCE. THE COMPANY RELIES ON INTERNAL CALIBRATION METHODS THAT ARE NOT TRACEABLE TO ANY NATIONAL OR INTERNATIONAL STANDARD, VIOLATING FUNDAMENTAL FDA REQUIREMENTS FOR DEVICE ACCURACY AND MEASUREMENT TRACEABILITY. AS A RESULT, NUMEROUS ANATOMICAL MODELS--USED BY SURGEONS TO MAKE CRITICAL PREOPERATIVE DECISIONS--HAVE BEEN PRODUCED WITH SIGNIFICANT DIMENSIONAL INACCURACIES. THESE INACCURACIES CAN LEAD TO SERIOUS SURGICAL ERRORS, INCLUDING INCORRECT IMPLANT SIZING, MISALIGNED BONE CUTS, AND NEUROVASCULAR INJURIES. THE ABSENCE OF THESE MEASURES RENDERS THE DEVICE ADULTERATED AND MISBRANDED UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (FD&C), AND ITS CONTINUED USE POSES A SIGNIFICANT AND UNJUSTIFIED THREAT TO PATIENT SAFETY. REFERENCE REPORTS:MW5170785.