MAUDE Adverse Event Report: DENTSPLY LLC SCHICK33 S2 STARTER KIT/3.0 INTERFACE 9'; UNIT, X-RAY, INTRAORAL

Catalog Number	100008634
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- solution description 01/23/2026 16:35:47 rebecca buck (rbuck) troubleshooting description: artifacts in sensor.They just started using the sensor and noticed the artifact in a corner.They noticed after a few images on one patient.Attached.She took a test on herself and i posted it.The artifact does not appear in blank area.Attached.I did a session on op2 and see firmware version and updated.
Event or Problem Description
While the customer was using a part of an intraoral sensor system, schick33 s2 starter kit/3.0 interface 9', they allege experiencing image quality issues when an x-ray image was taken and an additional image was required.No injury was reported from the alleged event.
Additional Manufacturer Narrative
This is to correct and remove the codes that were initially reported - removing codes for: type of investigation : 4118.Investigation findings code: 3233.Investigation conclusions : 11.The correct codes for this complaint are: type of investigation : 10.Investigation findings code: 4214.Investigation conclusions : 4318.This is a follow up report to correct this code.

• Brand Name: SCHICK33 S2 STARTER KIT/3.0 INTERFACE 9'
• 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: 24336379
• Report Number: 2424472-2026-00536
• Device Sequence Number: 4914394
• Product Code: EAP
• UDI-Device Identifier: D0031000086340
• UDI-Public: D0031000086340
• Combination Product (Y/N): N
• PMA/510(K) Number: K093453
• 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): 03/20/2026

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: 100008634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/23/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown