BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED 4X28 MM

    MDR report key: 1370016 · Received January 4, 2007

    Report

    Report Number
    9610622-2007-00001
    Event Type
    Injury
    Date Received
    January 4, 2007
    Date of Event
    November 29, 2006
    Report Date
    December 12, 2006
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED. THERE IS NO INFO THAT STATES WHICH DEVICE IF ANY CAUSED THE ADVERSE EVENT. LIST OF ADDITIONAL DEVICES: 1896-4028S K591675 LOCKING SCREW, 1896-4036S K702394 LOCKING SCREW, 1896-4050S K702696 LOCKING SCREW, 1896-4045S K432156 K672848 LOCKING SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITIES: PT HAD SCREWS, WHICH HAD BEEN IMPLANTED IN 2006. REMOVED FROM LEFT SHOULDER SECONDARY TO PAIN AND PHYSICIAN NOTED SCREWS HAD "BACKED OUT". IN ACCORDANCE WITH HOSP POLICY THE COMPONENTS REMOVED ARE NOT AVAILABLE FOR RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 4X28 MM IMPLANT HWC STRYKER TRAUMA KIEL NA K646743

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention