BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINI KOMPRESSOR SCREW 18 MM

    MDR report key: 1993373 · Received February 8, 2011

    Report

    Report Number
    3004608878-2011-00012
    Event Type
    Other
    Date Received
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    INEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A RIGHT BUNION SURGERY PROCEDURE, THE PT'S BONE HAD CRACKED AS THE SURGEON ADVANCED THE TRAILING HEAD OF THE SCREW INTO THE BONE. STAPLES HAD TO BE USED TO FIX THE BONE FRAGMENTS. THE PT HAD MORE POST OPERATIVE PAIN THAN NORMALLY EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI KOMPRESSOR SCREW 18 MM MINI-KOMPRESSOR COMPRESSION SCREW SYSTEM HWC INEGRA LIFESCIENCES CORP. (INTEGRA-OHIO) 83411811049

    Patients

    Seq Age Sex Outcome Treatment
    1