BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW GOLD/SILVER CONTRA ANGLE

    MDR report key: 12532618 · Received September 27, 2021

    Report

    Report Number
    9611053-2021-00310
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Report Date
    October 12, 2021
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EGS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    CONTRA-ANGLE HANDPIECE 131133 (HEAD DRIVE) DEFECTIVE, REPLACED BY CONTRA-ANGLE HANDPIECE 128836 (2018).

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION HAS CAUSED FILE SEPARATION. SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A CONTRA ANGLE 6:1 FOR VDW.GOLD/SILVER STOPS DURING TREATMENT. IT ALSO MAKES UNUSUAL NOISES. NO PATIENT INJURY OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435565 VDW GOLD/SILVER CONTRA ANGLE HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1