BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-SMART PLUS VERSION 0202

    MDR report key: 20709564 · Received November 18, 2024

    Report

    Report Number
    8031010-2024-00143
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    November 6, 2024
    Report Date
    December 20, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FROM DENTSPLY SIRONA CHINA. THERE WAS NO PROBLEM WITH THE CLAMPING MECHANISM. IT¿S THE STUDENT DID NOT CHECK IF THE FILE WAS CLAMPED BEFORE USE. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS FINE.

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT/SERIAL NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT AN X-SMART PLUS VERSION 0202 THAT WAS USED DURING TREATMENT THE DESIGNATED STUDENT DID NOT CHECK IF THE CLAMP WAS NOT CHECKED FOR JAMMING, AND DID NOT USE A RUBBER DAM. AS A RESULT, THE FILE (M3) FELL INTO THE PATIENT'S MOUTH AND WAS SWALLOWED. THE PATIENT WAS IMMEDIATELY HOSPITALIZED. 6 DAYS LATER, THE PATIENT LEFT THE HOSPITAL AFTER THE FILE WAS EXPELLED FROM THE BODY. THE HEAD NURSE OF THE DEPARTMENT USED OTHER FILE TO CLAMP THE X-SMART PLUS MOTOR HEAD, CONFIRMING THAT THERE WAS NO PROBLEM WITH THE MOTOR HEAD AND IT COULD BE CLAMPED. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987362 X-SMART PLUS VERSION 0202 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS MAILLEFER INSTRUMENTS HOLDING SARL 02473819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown