ITERO ELEMENT 5D PLUS

Additional Manufacturer Narrative

BLOCK D1-6 (SUSPECT MEDICAL DEVICE). ALL THIS WAS UPDATED ACCORDING TO NEW INFORMATION RECEIVED.

Additional Manufacturer Narrative

ALIGN'S CLINICAL AND TECHNICAL REVIEW CONSIDERS THE OVERALL CIRCUMSTANCES OF THE EVENT, IT IS DETERMINED THAT THE INCIDENT DOES NOT INDICATE PERMANENT DAMAGE, PERMANENT IMPAIRMENT, OR THE NEED FOR SURGICAL INTERVENTION TO PREVENT SUCH OUTCOMES. HOWEVER, THE EVENT QUALIFIES AS A SERIOUS ADVERSE EVENT DUE TO ITS INHERENT POTENTIAL TO CREATE A LIFE-THREATENING SITUATION, WITH THE CAPABILITY OF CAUSING PERMANENT HARM OR EVEN DEATH UNDER DIFFERENT CIRCUMSTANCES. THE CLINIC DOCTOR HAS REPORTED THAT CURRENTLY THE FIRE DEPARTMENT AND INSURANCE COMPANY ARE DOING AN INVESTIGATION TO DETERMINE THE CAUSE OF THE EVENT, HE SAID IT WAS A POSSIBILITY THAT THE ITERO, A CURING LIGHT DEVICE OR BUILDING ELECTRICAL ISSUE WAS THE ROOT ISSUE, HOWEVER, HE WAS NOT SURE OF THE SOURCE OF THE FIRE. NO DEFINITIVE CAUSE HAS BEEN ESTABLISHED AND NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE SCANNER CAUSED OR CONTRIBUTED TO THE FIRE 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 SUSPECTED MEDICAL DEVICE, THEREFORE PART (D1, D4,G4 AND H4) HAVE NOT BEEN FILLED OUT, IF ADDITIONAL INFORMATION IS GATHERED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE CAUSE OF THE FIRE REMAINS UNKNOWN. NO ADDITIONAL DETAILS ARE AVAILABLE, BUT WE WILL PROVIDE UPDATES AS SOON AS NEW INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CLINIC DOCTOR REPORTED A FIRE IN THE FACILITY, CAUSING EXTENSIVE DAMAGE, INCLUDING THE LOSS OF MULTIPLE OPERATORIES, NUMEROUS DENTAL DEVICES, AND CONTAMINATION OF INVISALIGN CASES DUE TO FIRE DEBRIS AND SOOT. AMONG THE DESTROYED EQUIPMENT WAS A MOBILE ITERO UNIT, WHICH WAS COMPLETELY BURNED. NO PATIENT INJURIES AND NO DEVICE MALFUNCTIONS WERE REPORTED PRIOR TO THE FIRE.

Additional Manufacturer Narrative

THE CLINIC REPORTED THAT A FIRE OCCURRED WITHIN THE FACILITY, RESULTING IN SIGNIFICANT PROPERTY DAMAGE AND LOSS OF EQUIPMENT, INCLUDING AN ITERO SCANNER. NO PATIENT OR STAFF INJURIES WERE REPORTED IN ASSOCIATION WITH THIS EVENT. A FIRE INVESTIGATION WAS CONDUCTED BY THE INSURANCE COMPANY EXPERT TO DETERMINE THE ORIGIN AND CAUSE OF THE INCIDENT. AS PART OF THE EVALUATION, ALIGN TECHNOLOGY PROVIDED AN EXEMPLAR LUMINA (ITERO) SCANNER FOR COMPARATIVE ANALYSIS. THROUGH EXAMINATION OF THE EXEMPLAR DEVICE ALONGSIDE THE FIRE-DAMAGED UNIT, THE EXPERT DETERMINED THAT THE FIRE MOST LIKELY ORIGINATED EXTERNAL TO THE SCANNER. BASED ON THESE FINDINGS, THE ITERO DEVICE HAS BEEN EXONERATED AS A POTENTIAL SOURCE OR CONTRIBUTING FACTOR TO THE FIRE. NO EVIDENCE OF DEVICE MALFUNCTION WAS IDENTIFIED BEFORE OR DURING THE EVENT. ADDITIONALLY, THERE WERE NO REPORTED ADVERSE HEALTH EFFECTS, SERIOUS INJURIES, OR MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AS A RESULT OF THIS INCIDENT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THIS REPORT IS BEING DOCUMENTED FOR RECORD-KEEPING PURPOSES. ALIGN WILL CONTINUE TO MONITOR ANY NEW OR ADDITIONAL INFORMATION AND WILL REASSESS REPORTABILITY IF WARRANTED. BLOCK H6 (DEVICE MANUFACTURERS ONLY) WAS UPDATED ACCORDING TO NEW INFORMATION RECEIVED.