ITERO ELEMENT 2

Description of Event or Problem

AS PART OF FOLLOW UP ACTIVITIES, ALIGN CONTACTED THE CLINIC SEVERAL TIMES WITH NO RESPONSE. ON (B)(6) 2026 THE CLINIC CONFIRMED THAT THE PATIENT HAD RETURNED FOR A SUBSEQUENT VISIT AND WAS DOING WELL. THE CLINIC FURTHER REPORTED THAT, AT THE EMERGENCY ROOM IT WAS CONFIRMED THAT THE IMPLANTED DEVICE HAD NOT MOVED, AND NO SPECIAL MEDICAL PROCEDURES WERE REQUIRED. NO ADDITIONAL DETAILS REGARDING THE IMPLANT TYPE OR MEDICAL FINDINGS WERE AVAILABLE. AS FOR THE REPORTED LOCKED JAW AT THE TIME OF THE INCIDENT, THE CLINIC CONFIRMED THAT THE PATIENT WAS DOING WELL AND HAD NO CONSEQUENCES LEFT.

Additional Manufacturer Narrative

ALIGN'S CLINICAL REVIEW OF THE AVAILABLE RECORDS AND INFORMATION INDICATES THAT, ALTHOUGH IT CANNOT BE COMPLETELY EXCLUDED THAT THE DEGREE OF MOUTH OPENING DURING THE SCANNING PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED JAW LOCKING, ADDITIONAL CLINICAL HISTORY IS REQUIRED TO ESTABLISH A DEFINITIVE DIAGNOSIS AND TO EVALUATE THE POSSIBILITY OF A PREEXISTING TEMPOROMANDIBULAR JOINT (TMJ) CONDITION. FOLLOWING THE INVESTIGATION OF THE REPORTED IMPLANT SHIFTING CASE AND THE RISK ASSESSMENT PERFORMED BY THE MANUFACTURER, IT WAS DECIDED THAT THE REPORTED SYMPTOM OF A "CRANIAL IMPLANT MOVED" DOES NOT SUGGEST PERMANENT IMPAIRMENT, AS THE PATIENT'S MAGNET DID NOT ACTUALLY SHIFT, NO MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT IS CURRENTLY DOING WELL. THE ITERO ELEMENT 2 PLATFORM RISK ANALYSIS INCLUDES AN EXISTING RISK ADDRESSING ELECTROMAGNETIC EMISSIONS AND THEIR POTENTIAL INTERACTION WITH OTHER MEDICAL DEVICES. THIS RISK IS DOCUMENTED IN THE MAIN TAB, TITLED "ELECTRIC / MAGNETIC FIELDS - RADIATED EMISSION." CONSIDERS THE HAZARDOUS SITUATION IN WHICH ELECTROMAGNETIC EMISSIONS FROM THE SYSTEM COULD INTERFERE WITH OTHER MEDICAL DEVICES USED IN THE CLINIC ENVIRONMENT OR ON THE PATIENT. THE ASSOCIATED POTENTIAL HARM IS DEFINED AS HARM TO OTHER MEDICAL DEVICES OR IMPLANTABLE DEVICES OR THEIR HOST PATIENTS. THE RISK IS ASSESSED AS ACCEPTABLE, BASED ON THE SEVERITY AND PROBABILITY ESTIMATES AND THE IMPLEMENTED MITIGATIONS.THE SYSTEMS ARE IN COMPLIANCE WITH IEC 6060112 ELECTROMAGNETIC COMPATIBILITY (EMC) REQUIREMENTS. FOLLOWING APPLICATION OF THIS MITIGATION, THE RISK REMAINS ACCEPTABLE AND THE RISK LINE IS MARKED AS CLOSED. THIS RISK THEREFORE ALREADY EXISTS WITHIN THE PRODUCT RISK MANAGEMENT FRAMEWORK AND WAS NOT NEWLY INTRODUCED BY THE REPORTED COMPLAINT. OVERALL, THIS INCIDENT DOES NOT MEET THE CRITERIA FOR A LIFE-THREATENING ILLNESS, PERMANENT IMPAIRMENT, PERMANENT DAMAGE TO A BODY FUNCTION OR STRUCTURE, NOR DOES IT QUALIFY AS A SERIOUS INJURY OR SERIOUS ADVERSE EVENT RELATED TO THE USE OF THE PRODUCT, AND IT IS NOT CLASSIFIED AS A NEW RISK TO THE SYSTEM. BLOCK B5 (DESCRIBE EVENT OR PROBLEM), B7 (OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS), BLOCK D1-6 (SUSPECT MEDICAL DEVICE). BLOCK G3 WAS BASED ON THE DATE WE CONFIRMED THE DEVICE USED; HOWEVER, THE DATE THE UPDATE WAS RECEIVED BY THE OFFICE ASSISTANT WAS ON 1/28/2026. THE UPDATED SECTIONS ARE APPLICABLE ACCORDING TO NEW INFORMATION RECEIVED FROM THE CLINIC AND AS PART OF THE INVESTIGATION AND RISK ASSESSMENT.

Additional Manufacturer Narrative

ALIGN'S CLINICAL REVIEW CONSIDERS THE INCIDENT DOES NOT MEET THE CRITERIA FOR A LIFE-THREATENING ILLNESS, BUT MAY HAVE CONTRIBUTED TO AFFECTING THE PATIENT'S HEALTH, THEREFORE IT WILL BE CONSIDERED SERIOUS. FURTHER EVALUATION AND CONSULTATION WITH THE IMPLANT MANUFACTURER WOULD BE NECESSARY TO FULLY EXCLUDE RISKS IN PATIENTS WITH ACTIVE IMPLANTABLE DEVICES. THEREFORE, NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE SCANNER CAUSED OR CONTRIBUTED TO THE MAGNETS MOVING (OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) AND THE ITERO SCANNER WAS BEING USED. THEREFORE, AN MDR IS BEING FILED IN THE UNITED STATES PER 21 CFR 803. THERE IS NO CONCLUSIVE EVIDENCE TO CONFIRM THE BRAND NAME, THEREFORE PART (D1, D4, G4 AND H4) HAVE NOT BEEN FILLED OUT, IF ADDITIONAL INFORMATION IS GATHERED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

A PEDIATRIC PATIENT WITH AN UNSPECIFIED AUTOIMMUNE CONDITION AND UNKNOWN CRANIAL MAGNET WAS SCANNED. LATER THAT DAY, THE PATIENT'S MOTHER REPORTED THAT MAGNETS IMPLANTED IN THE CHILD'S HEAD HAD SHIFTED, CAUSING AN INTERNAL MALFUNCTION AND LOCKED JAW. THE MOTHER STATED SHE CONTACTED CUSTOMER AND WAS TOLD THE PATIENT SHOULD NOT HAVE BEEN SCANNED WITH HER IMPLANTS; SHE THEN TOOK THE CHILD TO THE ER. NO SYMPTOMS BEYOND IMPLANT MOVEMENT AND LOCKED JAW WERE DESCRIBED, AND NO ER RECORDS OR IMPLANT DETAILS ARE AVAILABLE. THE DEVICE OPERATED NORMALLY WITH NO REPORTED MALFUNCTION.