BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16DEG 42MM REJUVENATE NECK

    MDR report key: 2910423 · Received January 8, 2013

    Report

    Report Number
    9616680-2013-90070
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    March 8, 2012
    Report Date
    December 19, 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
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT AN IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND WOUND DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9843 16DEG 42MM REJUVENATE NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention