BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE NECK

    MDR report key: 2926238 · Received January 16, 2013

    Report

    Report Number
    9616680-2013-90139
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    January 17, 2011
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: ALLEGEDLY, PATIENT HAS SUSTAINED PERSONAL INJURIES "AS THE RESULT OF THE RECALLED STRYKER REJUVENATE MODULAR STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24084 UNKNOWN REJUVENATE NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other