MAUDE Adverse Event Report: DENTSPLY LLC SCHICK33 S2 SENSOR SHIP KIT, 9FT; UNIT, X-RAY, INTRAORAL

Catalog Number	B1218001
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 02/02/2026 10:24:14 (b)(6).Initial log 02/02/2026 9:49:14 am (dentsply sirona charlotte time) warranty: no dealer on-site:yes billable:na canada.Remote access: yes sidexis version: 4.3.1 server location: dental server pdata remote location: \\dentalserver\pdata rcu location (if applicable): practice management: workstation(s): op2 scout check: firmware: 2.38 plug-in version: 2.2 & 5.16.Troubleshooting description: since server upgrade and windows 11 upgrade they get occasional white images for sensor # (b)(6).Registered that sensor.Did session on pc op2 and removed old 5.16 driver and repaired 2.2.It did not bring up the configuration.I launched it and entered server name.It has pending reboot for windows updates.Used tech toolbox to install missing c++.Rebooted for updates.Reinstalled driver 2.2 and tested in sidexis 4.3.1 okay.He will return for us to address extra usb s in network devices and restart service.Took screen shot of one of 2 patients with the white image.They saw the white image are retook image once.No injuries.He will repeat the procedure to remove the old driver and update pcs as needed.Note 02/06/2026 17:24:42 (b)(6).Further action office repeated fix on multiple workstations and got the drivers working.Only one extra retake was mentioned during the ticket not after.
Event or Problem Description
While the customer was using a part of an intraoral sensor system, schick33 s2 sensor ship kit, 9ft, 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.

• Brand Name: SCHICK33 S2 SENSOR SHIP KIT, 9FT
• 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: 24484900
• Report Number: 2424472-2026-00584
• Device Sequence Number: 14725498
• Product Code: EAP
• UDI-Device Identifier: D003B12180010
• UDI-Public: D003B12180010
• 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): 03/02/2026

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: B1218001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown