BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER

    MDR report key: 962664 · Received December 12, 2007

    Report

    Report Number
    8031010-2007-00208
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION PATIENT INJURY RESULTED OR THAT INTERVENTION WAS REQUIRED, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. FURTHER INFORMATION PERTAINING TO THIS EVENT, INCLUDING EVALUATION RESULTS, WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIX ANKER POST SEPARATED APPROXIMATELY NINETEEN MONTHS AFTER PLACEMENT; OUTCOME OF THE EVENT IS UNK AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIX ANKER ELR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR TELESCOPE PROSTHESIS