BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SYSTEM

    MDR report key: 2437047 · Received February 2, 2012

    Report

    Report Number
    1030489-2012-00105
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE UNITED STATES, HOWEVER, A LIKE DEVICE, PART NUMBER 9392508, 510K NUMBER K094025, IS APPROVED FOR SALE IN THE UNITED STATES. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT INDICATE ANY APPLICABLE NON-CONFORMANCES TO SPECIFICATIONS OR DEVIATIONS IN PROCEDURE. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEK INTERBODY DEVICE WAS BROKEN DURING INSERTION AT L5-S1. ALL FRAGMENTS WERE REMOVED AND ANOTHER DEVICE WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SYSTEM MAX MSD DEGGENDORF MFG TY99

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention