BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2112652 · Received April 29, 2011

    Report

    Report Number
    8030965-2011-00208
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER ASSOCIATED WITH DEVICE ONLY SOLD IN (B)(4). INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. NO ADDITIONAL INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE HEAD OF THE MF CORTEX SCREW BROKE OFF DURING SCREW REMOVAL FROM THE ORBITAL BONE. THE BROKEN FRAGMENTS WILL REMAIN IN THE PT. SURGEON DOES NOT PLAN TO REVISE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI