BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NECK

    MDR report key: 2915613 · Received January 10, 2013

    Report

    Report Number
    9616680-2013-90081
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    January 30, 2012
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN 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 PATIENT IS EXPERIENCING PAIN IN HIS GROIN AREA. PATIENT ALSO STATES THAT HE IS EXPERIENCING SWELLING, REDUCED MOBILITY, PAIN ACROSS THE THIGH AND SWELLING IN BUTTOCK AREA. PATIENT HAS HAD BLOOD TEST AND X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15330 REJUVENATE MODULAR NECK IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 33133801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other