BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L22 SST

    MDR report key: 2873920 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01579
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    August 20, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: WHEN OPENING THE CORTEX SCREW BOX, STILL SEALED, A BUG WAS FOUND INSIDE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTSCR Ø3.5 L22 SST CORTSCREW HWC SYNTHES GMBH 3383081

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR