MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. AC-GM ESSIX ALIGNER CHEWIE GREEN MINT 20PK; PUSHER, BAND, ORTHODONTIC

Catalog Number	AC-GM
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
In this event it is reported that ac-gm essix aligner chewie green mint 20pk that a patient used caused an allergic reaction.The patient experienced throat and face swelling.The patient was hospitalized and treated for anaphylaxis and given steroids overnight.They were discharged the following day, the doctors advised the patient their anaphylaxis was caused by the chewies and to cease use.Patient had no known allergies prior to this event.
Additional Manufacturer Narrative
2 documented attempts(follow ups) have been made to receive product for investigation and tracking #.This information has not been received.Dhr investigation will be conducted.8-2-2024: dhr for item# ac-gm essix aligner chewie green mint 20pk batch# 07084909 has been pulled, reviewed, and attached to this case.Dhr review only identified issues with print quality issues throughout the autobagging portion of the manufacturing work order.All other inspections were performed and deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-50-16, 0290-ip-7.5-30-02, 0290-ip-7.5-50-07 and 0290-wss-7.5-50-07.The number of raw materials and amount per picked and consumed to the work order are exactly as the bom required.Raw materials used to make the ac-gm chewies as per 0290-spec-028 (material specifications for chewies aligner seaters) for this production order are item# gnlr (glenroe non latex raw material) batch# 04eaf1031 & item# tb green (mc-24243ev) batch# 7071727, item# spearmint 9295629 spearmint scent) batch# 210506567.Receiving inspections/documentation for all 3 raw materials also pulled, reviewed, and attached to this dhr.Each inspection was completed by quality and documented in each respective receiving inspection history sheets.Coa¿s for each material were verified against 0290-spec-028 and are conforming.(nwv) 8-2-2024: retains were not available for review as per 0290-wi-8.2-07 which states retention samples must be maintained for a minimum of six months (produced 06-2023).(nwv) failure mode: allergic reaction.Root cause: no defect proven.Conclusion code: no failure found.

• Brand Name: AC-GM ESSIX ALIGNER CHEWIE GREEN MINT 20PK
• Common Device Name: PUSHER, BAND, ORTHODONTIC
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19816018
• Report Number: 1036212-2024-00001
• Device Sequence Number: 8665935
• Product Code: ECS
• UDI-Device Identifier: D746ACGM1
• UDI-Public: D746ACGM1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: AC-GM
• Device Lot Number: 07084909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/02/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown