BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD KOMPRESSOR SCREW 18 MM

    MDR report key: 1981373 · Received February 3, 2011

    Report

    Report Number
    3004608878-2011-00010
    Event Type
    Other
    Date Received
    February 3, 2011
    Date of Event
    November 20, 2010
    Report Date
    February 3, 2011
    Manufacturer
    INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)
    Product Code
    HBL
    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 INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A BUNION CORRECTION SURGICAL PROCEDURE, THE PT'S BONE HAD CRACKED AS THE TRAILING HEAD OF THE SCREW WAS BEING ADVANCED. THE SURGEON HAD TO USE STAPLES FOR FIXATION OF THE BONE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD KOMPRESSOR SCREW 18 MM KOMPRESSOR COMPRESSION SCREW SYSTEM HBL INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO) 8341181060

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention