BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 34MM

    MDR report key: 3140710 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01834
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    July 6, 2012
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AN UNKNOWN REJUVENATE/ABG II NECK. THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.A VOLUNTARY RECALL RA (B)(4) WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL (B)(4) WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED EVENT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STRYKER PRODUCT. THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    INITIAL AND SUPPLEMENTAL MDR WERE MISTAKENLY SUBMITTED TO FDA THROUGH NORMAL ELECTRONIC FILING. THIS MDR WILL BE RESUBMITTED VIA A (B)(4) REPORT AS PART OF THE REQUIREMENT OF (B)(4).

    Description of Event or Problem · 1

    AS PER LEGAL CORRESPONDENCE, PATIENT HAS SOUGHT LEGAL COUNSEL CONCERNING INJURIES HE SUSTAINED IN AN INCIDENT OCCURRING ON OR ABOUT (B)(6), 2012 WHICH INVOLVED THE INSURED, STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    AS PER LEGAL CORRESPONDENCE, PATIENT HAS SOUGHT LEGAL COUNSEL CONCERNING INJURIES HE SUSTAINED IN AN INCIDENT OCCURRING ON OR ABOUT (B)(6) 2012 WHICH INVOLVED THE INSURED, STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    AS PER LEGAL CORRESPONDENCE, PATIENT HAS SOUGHT LEGAL COUNSEL CONCERNING INJURIES HE SUSTAINED IN AN INCIDENT OCCURRING ON OR ABOUT (B)(6) 2012 WHICH INVOLVED THE INSURED, STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    AS PER LEGAL CORRESPONDENCE, PATIENT HAS SOUGHT LEGAL COUNSEL CONCERNING INJURIES HE SUSTAINED IN AN INCIDENT OCCURRING ON OR ABOUT (B)(6) 2012 WHICH INVOLVED THE INSURED, STRYKER ORTHOPAEDICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242145 LRG TAP PRI MOD NCK 0DEG 34MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 36804502

    Patients

    Seq Age Sex Outcome Treatment
    1 Other