BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS LOCKING CAPS

    MDR report key: 940429 · Received April 17, 2007

    Report

    Report Number
    9617544-2007-00019
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    March 23, 2007
    Report Date
    March 23, 2007
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    JDT
    PMA / PMN Number
    K062270
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUPPLIED ON A SUPPLEMENTAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "T4-PELVIS HYBRID CONSTRUCT (90D+RADIUS). TOP CAP OF CONSTRUCT T4 POPED OFF. SEEN ON POST OP VISIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIUS LOCKING CAPS IMPLANT JDT STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other