MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. ASPEN MOTTO NONTEMPLATE ALIGNER ARCH; ALIGNER, SEQUENTIAL

Catalog Number	ASSY-500018
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Laceration(s) (1946); Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Event or Problem Description
In this event it is reported that aspen motto nontemplate aligner arch has sharp edges.The sharp edges on the aligners where filed down but the patient experienced the sharp edges cutting into their gums.
Additional Manufacturer Narrative
Failure mode: sharp edges.Root cause: not determined - after reviewing the records generated during the manufacturing process and lab tests, we found no deviations during the process that could cause the alleged event issue.Conclusion code: indeterminable.Dhr evaluation: we reviewed the dhr for this so-091so0013810 / patient id# (b)(6) / practice id# (b)(4), qty.(b)(4) assy-500011 (aligner), qty.(b)(4) assy-500010 (templates), were packaged by the second shift by bag and box operation on (b)(6) 2023, manufacturing supercell sc0, equipment bag-14.The sales order was inspected and met with the acceptance criteria provided by qa.Photo investigation the evidence provided by the customer shows an upper aligner placed on the patient's maxillary teeth.We observed a gap between the aligner and the gum, in the area of the right molars.The aligner shows an apparent deformation with a flared edge in that area.Replication investigation.According to the description of the alleged event, we based the development of the investigation on the aligners of stage 1 upper of the sales order (b)(4).Lab test: we started by requesting the digital file of arch u1 (sn: (b)(6)), from the original order to replicate the arches according to the digital specifications.Printing operation: we re-printed the arch u1 (sn:(b)(6)), with the same characteristics and specifications as the original arch manufactured in this sales order.Deep draw operation: thermoformed on foil round plastic 0.030¿ the aligner u1 (sn: (b)(6)), peeling the green film from the aligner.Result lab test.We obtained aligner u1 (sn: (b)(6)) according to the specifications of the original order, the alleged event issue was not replicated during the lab test.The replicated aligner shows no deformations or sharp edges related to the alleged event.

• Brand Name: ASPEN MOTTO NONTEMPLATE ALIGNER ARCH
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19573591
• Report Number: 1649995-2024-00016
• Device Sequence Number: 8524828
• Product Code: NXC
• UDI-Device Identifier: 00856379007283
• UDI-Public: 00856379007283
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASSY-500018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/31/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown