BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA SCREW 6, 5 X 40

    MDR report key: 2097223 · Received May 11, 2011

    Report

    Report Number
    9617544-2011-00169
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    June 23, 2010
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNI
    PMA / PMN Number
    K002858
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#K002858, LTFS, K060361. ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    STRYKER RECEIVED AN INCIDENT INFO FROM (B)(4) STATING THE FOLLOWING: IMPLANTATION (TRANSFORAMINELLE LUMBALE INTERKORPORELLE FUSION L4-S1) ON (B)(6) 2009 AT THE HOSPITAL (B)(6). BREAKAGE OF THE SCREW S1 ON BOTH SIDES BETWEEN (B)(6) 2009 AND (B)(6) 2010. THIS PER IS RAISED ON MINIMAL INFO. ON 04/19/2011: SOME FURTHER INFO REGARDING THE PT AND SURGERY DATES RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA SCREW 6, 5 X 40 IMPLANT MNI STRYKER SPINE BORDEAUX UNDETERMINED

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O| R REPORT.| LOT NUMBERS AT THIS TIME ARE THE SUBJECT OF THIS| 2 SCREWS OF SAME CATALOG NUMBER WITH UNDETERMINED