BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREWDRIVER GAMMA 3 380 X 110 MM

    MDR report key: 2625697 · Received June 14, 2012

    Report

    Report Number
    9610622-2012-00261
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 28, 2012
    Report Date
    May 28, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS ¿ KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN AT THIS TIME IF THE DEVICE IS BEING RETURNED FOR EVAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICE: (B)(4) LAG SCREW, TI GAMMA 3 10.5 X 75 MM, LOT# K137926.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHEN THE SURGEON WAS ATTEMPTING TO ATTACH THE LAG SCREW TO THE LAG SCREW DRIVER, THE LAG SCREW WOULD NOT FULLY SEAT WHICH RESULTED IN THE LAG SCREW NOT FULLY ENGAGING THE TEETH AT THE DISTAL TIP OF THE LAG SCREW DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREWDRIVER GAMMA 3 380 X 110 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS ¿ KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other