BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER DENTAL POSTS

    MDR report key: 772249 · Received June 9, 2006

    Report

    Report Number
    8031010-2006-00280
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Report Date
    May 11, 2006
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS EVENT, IT WAS REPORTED THAT A RADIX ANKER POST SEPARATED, FURTHER INFORMATION HAS BEEN REQUESTED, THOUGH NONE IS AVAILABLE AS OF THIS REPORT. WHILE THERE IS NO INDICATION THAT A PATIENT WAS INJURED OR REQUIRED INTERVENTION, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION. THEREFORE, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. 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 SEPARETED. FURTHER INFORMATION HAS BEEN REQUESTED, THOUGH NONE IS AVAILABLE AS OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN