BEUDAMED
    FDA Adverse Event Summary report: N

    LOCKING SCREW

    MDR report key: 1032504 · Received April 14, 2008

    Report

    Report Number
    8031020-2008-00014
    Date Received
    April 14, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K050512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF THE DEVICE FOR ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, SURGEON WAS PUTTING THE SCREW IN UNDER POWER WHEN IT STRIPPED OFF AND METAL SHAVINGS WENT INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other