MAUDE Adverse Event Report: DENTSPLY LLC SCHICK AE USB INTERFACE, RMA; UNIT, X-RAY, INTRAORAL

Catalog Number	100008290
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While the customer was using a part of an intraoral sensor system, schick ae usb interface, they allege there was an x-ray image transmission issue where the x-ray image was not captured after radiation has occurred (transmission failure).No injury was reported from the alleged event.
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.Usb 3 firmware v1.4 contains an issue in the portion of code used to optimize sensor performance.If the optimization occurs during an exposure or sensor readout, there is a chance that the resulting image will be corrupted.Image data following the point of corruption will consist of data that was previously held in the memory of the usb device.As a result, the presented image may contain a portion of data from a previous exposure.In general, this would be obvious to the user since the presented image would either contain obvious artifacts or different anatomy than expected.Field service evaluation- problem description (b)(6) 2026, 14:21:16, (b)(6).Initial log- (b)(6) 2026 4:16:09 pm (b)(6).Warranty: yes dealer technician on-site: no billable: no (equipment under warranty) remote access: sidexis version: server location: pdata remote location: rcu location (if applicable): practice management: workstation(s): scout check: firmware: plug-in version: exposure count: unit ip address: troubleshooting details: the usb interface is not capturing images when the sensor is exposed to radiation when they try to retake images, some are able to process and others are not sent to sidexis recommended to have the usb interface replaced this occurs with and without patients no injuries reported.Replaced part.

• Brand Name: SCHICK AE USB INTERFACE, RMA
• Common Device Name: UNIT, X-RAY, INTRAORAL
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24430305
• Report Number: 2424472-2026-00573
• Device Sequence Number: 10304363
• Product Code: EAP
• UDI-Device Identifier: D0031000082900
• UDI-Public: D0031000082900
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: 100008290
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown