PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

Additional Manufacturer Narrative

THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. POST-OPERATIVE RADIOGRAPHS DEMONSTRATED THAT THE DEVICE HAD FRACTURED. THE SURGEON DOES NOT BELIEVE THE IMPLANT CONSTRUCT FAILURE WAS RELATED TO THE DESIGN OF THE 4WEB IMPLANT BUT WAS ATTRIBUTED TO EXISTING PATIENT COMORBIDITIES.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN APPROXIMATELY TWO AND A HALF YEARS POST-OP. THE COMPANY WAS NOTIFIED THAT A REVISION SURGERY WAS REQUIRED. DURING THE REVISION SURGERY, THE 4WEB DEVICE WAS EXPLANTED AND A DIFFERENT TECHNIQUE AND APPROACH WERE USED. NO COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.