MAUDE Adverse Event Report: DENTSPLY LLC SCHICK AE S2 SENSOR RMA, 6FT; UNIT, X-RAY, INTRAORAL

Catalog Number	100007049
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
This event requires medical intervention to retake the x-ray image.This also exposes the patient to additional radiation due to the need to retake the x-ray image.As such, this event meets the criteria for reportability per 21 cfr part 803.The sensor was replaced.
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.

• Brand Name: SCHICK AE S2 SENSOR RMA, 6FT
• 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: 24383868
• Report Number: 2424472-2026-00548
• Device Sequence Number: 13388016
• Product Code: EAP
• UDI-Device Identifier: D7641000070491
• UDI-Public: D7641000070491
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 100007049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown