BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIS PÉDICULAIRE POLYAXIALE Ø5,5 LG50

    MDR report key: 5616467 · Received April 28, 2016

    Report

    Report Number
    3003853072-2016-00037
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    July 27, 2015
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED COMPLAINT AND VISUAL EVALUATION OF THE RETURNED DEVICE, NO ADDITIONAL EVALUATION WILL BE PERFORMED AS THERE IS NO REPORTED FAILURE OF THIS DEVICE OR VISUAL DAMAGE IDENTIFIED. REPORT FIVE OF FIVE FOR THE SAME EVENT, REFERENCE 3003853072-2015-00016-3, 3003853072-2016-00011-1, 3003853072-2016-00012-1 AND 3003853072-2016-00036. THIS REPORT WAS COMPLETED BASED ON THE RECEIPT OF A LOT NUMBER WHICH WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2015 IT WAS DISCOVERED THAT THE LEFT SACRAL SCREW WAS FRACTURED. THE PATIENT REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270997 VIS PÉDICULAIRE POLYAXIALE Ø5,5 LG50 PEDICLE SCREW NKB ZIMMER SPINE N/A H21408F

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R