BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW AXSOS 4.0MM / L40MM

    MDR report key: 2140573 · Received June 16, 2011

    Report

    Report Number
    8031020-2011-00140
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING THE FINAL TIGHTENING OF THE SCREW IN THE SHAFT OF A PROXIMAL LATERAL TIBIA PLATE, THE DOCTOR TOOK OFF THE TORQUE LIMITER FOR FINAL TIGHTENING AND BROKE THE SCREW HEAD. THE OTHER PART OF THE SCREW REMAINED IMPLANTED SECURELY. THE SCREW HEAD WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW AXSOS 4.0MM / L40MM IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other