BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2103802 · Received May 18, 2011

    Report

    Report Number
    8030965-2011-00239
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 31, 2008
    Report Date
    May 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. UNABLE TO PROVIDE THE MANUFACTURER, PMA/510K NUMBER, AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A CLINIC IN (B)(6) REPORTED: PATIENT STATUS POST NON-SYNTHES PLATE AND SYNTHES SCREWS IMPLANTATION, BECAME AWARE A FEW WEEKS LATER THAT FOUR OF NINE SCREWS BROKE. IT WAS NOTED THAT MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THIS IS ONE OF FOUR 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 66 YR Required Intervention