BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 34MM

    MDR report key: 2821429 · Received October 23, 2012

    Report

    Report Number
    9616680-2012-00919
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. INFORMATION RECEIVED INDICATED THAT THE HOSPITAL IS SENDING THE EXPLANTED DEVICES TO OUTSIDE LAB FOR TESTING. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS: MFR # 2249697-2012-01995.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED A REJUVENATE STEM, NECK AND HEAD ON PATIENT DUE TO ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 0DEG 34MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25520702

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention