MAXILLARY SKELETAL EXPANDER

Description of Event or Problem

I HAD AN ADVERSE REACTION TO THE GREAT LAKES MAXILLARY SKELETAL EXPANDER. THE DEVICE CAUSED SEVERE MUCOSAL PAIN, MUCOSAL OVERGROWTH IN THE SETTING OF GOOD ORAL HYGIENE, AND RESULTED IN A SMALL AREA OF BROKEN SINUS BONE AT ONE OF THE SCREW PLACEMENTS. THE DEVICE WAS PLACED (B)(6) 2023, AND REMOVED (B)(6) 2023 DUE TO THESE REACTIONS. THE WORKING ASSUMPTION OF MY PROVIDER TEAM IS THAT I HAD A SENSITIVITY TO THE METAL WHICH IS UNDERSTOOD TO BE STAINLESS STEEL.