BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    17MM TYPE "B" DIST.CENT.MODIFI

    MDR report key: 2220530 · Received July 18, 2011

    Report

    Report Number
    9616680-2011-00478
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K936127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "WHEN THE CIRCULATOR OPENED THE IMPLANT THE SCRUB TECH REALIZED THAT THE IMPLANT WAS BROKEN. THE CENTRALIZER WAS BROKEN IN HALF. WE OPENED THE NEXT SIZE CENTRALIZER DOWN AND IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 17MM TYPE "B" DIST.CENT.MODIFI IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 22641101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other