BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 16DEG 30MM

    MDR report key: 2912053 · Received January 11, 2013

    Report

    Report Number
    0002249697-2013-00030
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DUE TO HOSPITAL POLICY. 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT.THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL (B)(4) WAS INITIATED FOR REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED ADVERSE LOCAL TISSUE REACTION IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD ADVERSE TISSUE REACTION.

    Description of Event or Problem · 1

    PATIENT HAD ADVERSE TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16894 LRG TAP PRI MOD NCK 16DEG 30MM IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 23328901

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention