BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHICK33 S2 SENSOR SHIP KIT, 6FT

    MDR report key: 24484959 · Received March 2, 2026

    Report

    Report Number
    2424472-2026-00585
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Report Date
    March 2, 2026
    Manufacturer
    DENTSPLY LLC
    Product Code
    EAP
    UDI-DI
    D003B12180000
    PMA / PMN Number
    K093453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 ON 02/05/2026 17:36:27, (B)(6). FURTHER ACTION: FURTHER ACTION: 02/05/2026 5:07:19 PM, (DENTSPLY SIRONA CHARLOTTE TIME). CALLER'S FULL NAME: (B)(6). CALLER'S ROLE: WARRANTY STATUS: OOW. BILLING PREVIOUSLY ACCEPTED: PROBLEM DESCRIPTION: 12023597 ELITE SENSOR TOO BRIGHT. TROUBLESHOOTING DESCRIPTION: FOUND HANDHELD DEVICE WAS NOT ABLE TO DROP ON TIME ON HANDHELD REMIX. SOLUTION DESCRIPTION: ADVISED TO DROP TIME THEY WERE HAVING ISSUES WITH ADJUSTING THE REMIX DEVICE. FUNCTIONAL (YES/NO): YES. PROBLEM DESCRIPTION: 02/04/2026 17:53:11, (B)(6) (DIYWJ409). INITIAL LOG: ON 02/04/2026 4:56:37 PM, (DENTSPLY SIRONA CHARLOTTE TIME). WARRANTY: NO WARRANTY, DEALER ON-SITE: NO, BILLABLE: BILLABLE, BILLING ACCEPTED: YES, BILLING APPROVED BY: (B)(6), 90 DAY EXPIRATION DATE: 05/05/2026. REMOTE ACCESS: DESKTOP-1ICLS5K, DESKTOP-LK18K89, DESKTOP-7631MP6, DESKTOP-41VEG7A, DESKTOP-82FR6QV. SIDEXIS VERSION: 4.3.1. SERVER LOCATION: \\ISKAYHYPERV\PDATA. PROBLEM DESCRIPTION: UNABLE TO USE THE SENSORS, THOUGHT THE ISSUE WAS THE SENSOR BUT A SIRONA REP CAME IN AND EVERYTHING WORKED ON HIS PC, BUT HIS FUNCTIONING SENSOR DIDN'T WORK ON THEIRS. TROUBLESHOOTING DESCRIPTION: TV CONNECTION. SIDEXIS 4.3.1 IS INSTALLED. SIDEXIS 4 SENSOR PLUGIN 1.1 IS INSTALLED. CDR ELITE DRIVER 5.13 IS INSTALLED. REMOVED SIDEXIS4SENSOR PLUGIN AND CDR ELITE DRIVER. SOLUTION DESCRIPTION 02/04/2026 17:53:11, (B)(6) (DIYWJ409). INITIAL LOG: 02/04/2026 5:00:09 PM, (DENTSPLY SIRONA CHARLOTTE TIME). SOLUTION DESCRIPTION: INSTALLED SIDEXIS 4 SENSOR PLUGIN 2.2. NOW ABLE TO ACQUIRE THE SENSOR IN SIDEXIS. TEST SHOT IS GOOD. OFFICE HAD TO TAKE MULTIPLE IMAGES ON PATIENTS DUE TO THIS ISSUE. OFFICE STATES NO PATIENTS WERE HARMED.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A PART OF AN INTRAORAL SENSOR SYSTEM, SCHICK33 S2 SENSOR SHIP KIT, 6FT, THEY ALLEGE EXPERIENCING CONNECTIVITY ISSUES WHEN AN X-RAY IMAGE WAS TAKEN OR AN ADDITIONAL IMAGE WAS REQUIRED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150879 SCHICK33 S2 SENSOR SHIP KIT, 6FT UNIT, X-RAY, INTRAORAL EAP DENTSPLY LLC D003B12180000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown