MAUDE Adverse Event Report: DENTSPLY LLC SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6'; UNIT, X-RAY, INTRAORAL

Catalog Number	100008624
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, 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
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- note: 01/15/2026 14:44:57 (b)(4).Further action: 01/15/2026 1:30:03 pm (dentsply sirona charlotte time).(b)(6).Caller's role: ds rep.Warranty status: in warranty.Billing previously accepted: n/a.Remote access: yes.Sidexis version: 4.4.Server location: lrcu.Pdata remote location: lrcu.Rcu location (if applicable): lrcu.Practice management: dentrix.Workstation(s): rm-op2-7410.Scout check: yes.Firmware: 1.5.14, plug-in version: exposure count: unit ip address: problem description: rep is on-site and called back because the sensors are not recognized in sidexis again but does not believe that it is hardware related and refused cable replacement.Troubleshooting description: connected to rmd-op2-7410.Solution description: installed missing prerequisites and confirmed the sensor is picked up in device manager and io config app.However, when we setup for exposure the sensor is not shown in sidexis at all *this is the actual issue he called about*.Started confirming sidexis prerequisites are installed.Installed all missing c++ and.Net.Rdp'd over to lrcu and corrected permissions on pdata; added everyone to have full control.Sensor still not seen in sidexis.Disconnected sensor and usb.Restarted io sensor services -- no change.Removed and re-installed ioss driver.Sidexis sees sensor and test exposure was successful.He tested on other pcs and they all work fine.For good measure he requested i connect to the other pcs and install the missing prerequisites: rmd-op3, rm-op4, rmd-op1-7410.Functional (yes/no): yes.Note: 01/14/2026 15:46:00 (b)(4).Further action: 01/14/2026 2:30:57 pm (dentsply sirona charlotte time).(b)(6).Warranty status: yes billing previously accepted: problem description: customer reports white images.Sirona rep now onsite.Office claims they tightened the screws and checked cables.Office also claims that issue happens on all sensors.They say its not every image.So, issues are intermittent.But customer does say that it happens with every patient.Troubleshooting description: since sirona rep is onsite, i advised for him to take sensors apart clean contacts with alcohol and reassemble.He went one step beyond and replaced the elastomeric strip we took a full image series 18 images to test.No issues whatsoever.

• Brand Name: SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6'
• 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: 24312372
• Report Number: 2424472-2026-00522
• Device Sequence Number: 20253004
• Product Code: EAP
• UDI-Device Identifier: D0031000086240
• UDI-Public: D0031000086240
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: 100008624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown