BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, MP, CROSS-PIN, DIAM 2.0X12MM, 5/PACKA

    MDR report key: 1931349 · Received November 11, 2010

    Report

    Report Number
    8010177-2010-00425
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP: THE HEAD OF THE SCREW AND PART OF THE SHAFT SEPARATED FROM THE PORTION OF THE SHAFT THAT WAS ALREADY IN THE PATIENT'S MANDIBLE. THE PORTION THAT HAD ALREADY BEEN INSERTED REMAINS IN THE PATIENT. THE SALES REP REPORTS THAT THE CORRECT BLADE WAS USED FOR INSERTION, AND ALL PROCEDURES WERE FOLLOWED CORRECTLY. SURGERY WAS SUCCESSFUL AFTER INCIDENT. THE PORTION OF SCREW THAT SEPARATED FROM THE SHAFT IS AVAILABLE TO SEND BACK IN TO REGULATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, MP, CROSS-PIN, DIAM 2.0X12MM, 5/PACKA IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK