MAUDE Adverse Event Report: ORMCO CORPORATION SPARK ADVANCED

Catalog Number	728-3031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had pain in the ll anterior region and also had migraines.Upon examination the doctor diagnosed an abscess in the #22 area with significant facial movement in that area and significant bone loss.Doctor recommended to patient to stay in current aligners and not move forward until infection clears and doctor speak with spark re about the movements for this patient.Patient experimented the following symptoms: pain in #22 area, swelling, irritation, severe headaches, tooth mobility and severe bone loss.In doctor opinion, this complaint would it likely cause a serious injury because the patient would be prone to another infection and suffer permanent tooth loss in #22 or even all of her lower anterior teeth.Patient started spark aligners on (b)(6) 2022.Her first refinement was delivered on (b)(6) 2023 and she was given aligners stages 1 to 7 of 1 week.Patient came back on (b)(6) 2023 and was given aligners stages 8 to 14 and called on (b)(6) 2023 and was on aligner stage 14 at that point.It was prescribed clindamycin and srp with minocycline placement.Patient is not fully recovered because pain and headaches have subsided but doctor is extremely concerned with her bone loss and possible loss of permanent teeth.
Additional Manufacturer Narrative
Based on the x-rays provided by the doctor, the bone level is the same as the patient already had general bone resorption before starting the treatment plan and general root resorption.Based on evidence, the patient had a pre-existing condition in tooth 22, root resorption with radiolucency in the apex of 22 (endo- and/or periodontal involvement).Due to the patient's bone level at the beginning of treatment, aligners should not have been used because there is a warning in aligner ifu pn 070-010 rev.H mentions: the health of the bone and gums which support the teeth may be impaired or aggravated.The lenghth of the roots of the teeth may be shortened during orthodontic treatment, which may become a threat to the longevity of the teeth.

• Brand Name: SPARK ADVANCED
• Common Device Name: SPARK ADVANCED
• Manufacturer (Section D): ORMCO CORPORATION; 200 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): SDS DE MEXICO; cto. sur 31, nelson; mexicali, baja california 21395 ; MX 21395
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821 ; 7148174396
• MDR Report Key: 17870867
• Report Number: 2016150-2023-00006
• Device Sequence Number: 7028340
• Product Code: NXC
• UDI-Device Identifier: 00889989084856
• UDI-Public: 00889989084856
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 728-3031
• Device Lot Number: 746266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic