BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 42MM

    MDR report key: 2934642 · Received January 30, 2013

    Report

    Report Number
    0002249697-2013-00461
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    October 18, 2010
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS ABGII MODULAR NECK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO PAIN INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THE SUPER AND CHS COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED REVISION DUE TO PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: PATIENT IS EXPERIENCING PAIN AND DISCOMFORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: PATIENT IS EXPERIENCING PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40769 LRG TAP PRI MOD NCK 0DEG 42MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 26845001.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other