BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2050542 · Received March 15, 2011

    Report

    Report Number
    8030965-2011-00074
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    October 18, 2010
    Report Date
    February 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER AND/OR THE DATE OF MFR AS NO PRODUCT IS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT IS RETURNING AND NO PART/LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A DEVICE REPORT RECEIVED FROM BELGIUM INDICATES A PT STATUS POST ROD AND SCREW CONSTRUCT IMPLANTED RETURNED TO SURGEON. AN X-RAY SHOWED ONE SCREW SLIPPED OFF THE ROD AT AN UNK LOCATION. NO SURGICAL INTERVENTION IS NOTED. THIS IS TWO OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI SCREW HWC SYNTHES GMBH NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ROD| LOCKING CAP