BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NECK

    MDR report key: 2896212 · Received December 28, 2012

    Report

    Report Number
    9616680-2012-01516
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    March 30, 2011
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS EXPERIENCING MID THIGH PAIN AND CAN'T SLEEP. PT HAS HAD BLOOD WORK AND MARS MRI DONE. PT IS SCHEDULED FOR REVISION SURGERY (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE MODULAR NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 24903301

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other