BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIX ANKER

    MDR report key: 3925386 · Received July 2, 2014

    Report

    Report Number
    8031010-2014-00007
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVALUATION OF THE DEVICE INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE THIS ISSUE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE 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 WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A RADIX-ANKER POST FRACTURED DURING TREATMENT. THE DOCTOR ATTEMPTED TO SURGICALLY REMOVE THE BROKEN PIECE, BUT WAS UNSUCCESSFUL. THE DOCTOR NOW PLANS TO EXTRACT THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385362 RADIX ANKER POST, ROOT CANAL ELR DENTSPLY MAILLEFER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability