BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NECK

    MDR report key: 2901583 · Received January 3, 2013

    Report

    Report Number
    9616680-2012-01536
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 3, 2010
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PT HAS PERSONAL INJURIES SUSTAINED ON (B)(6) 2010 AS THE RESULT OF THE RECALLED STRYKER REJUVENATE MODULAR STEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678 REJUVENATE MODULAR NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 33809301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other