BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REJUVENATE STEM EXTRACTOR

    MDR report key: 2902922 · Received November 29, 2012

    Report

    Report Number
    2249697-2012-02501
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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, THE WING NUT SNAPPED OFF DURING REMOVAL. A REPLACEMENT WAS ON HAND SO THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STEM EXTRACTOR INSTRUMENT MEH STRYKER ORTHOPAEDICS MAHWAH NA B5AHN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other