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

Catalog Number	100008286
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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- customer note (b)(6) 2026, 14:42:33, (b)(6).Issue reported: timing out after radiation equipment type and model: schick ae usb interface serial number: (b)(6).Confirm sensor cable color: grey acquisition software & version: es v24.20 issue in one or all rooms: all other sensors work with working remo tes in room(s) with issue: y.Pc name: restorative-2 schick driver version (programs and features): remote fw/fpga version: 1.5.14 0 sensor fw version: n/a.If remote issue: 2.0 or 3.0: tried different usb cable/usb port/bypassed usb hubs/extenders: y 3.0 r emote: tried on a 3.0 and 2.0 usb port/cable clip connected: y if sensor issue, replaced elastomer: na if sensor issue, tried diff erent sensor cable: na.If no response to radiation, confirmed xray head functional: na.Solution description (b)(6) 2026 , 10:13:56 , (b)(6).Solution description: patterson issued a replacement remote.
Event or Problem Description
While the customer was using a part of an intraoral sensor system, schick ae usb interface, they allege there was a device response issue where the x-ray image was not captured after radiation has occurred (no device output).No injury was reported from the alleged event.

• Brand Name: SCHICK AE USB INTERFACE
• 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: 24377046
• Report Number: 2424472-2026-00546
• Device Sequence Number: 5572712
• Product Code: EAP
• UDI-Device Identifier: D0031000082860
• UDI-Public: D0031000082860
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 100008286
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown