BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NECK

    MDR report key: 2884969 · Received December 12, 2012

    Report

    Report Number
    9616680-2012-01347
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 16, 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
    LA, 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 RECEIVED THE RECALL LETTER FROM HER SURGEON. THE PT REPORTS THAT SHE BEGAN HAVING A CONSTANT PAIN IN THE RIGHT HIP AREA, THIGH AND LOWER BACK APPROX ONE WEEK AGO. THE PT WILL CONTACT HER SURGEON TO SCHEDULE AN EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE MODULAR NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 23328502

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other