BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTEX SCREW S.T. Ø4.5X38MM

    MDR report key: 3230727 · Received July 17, 2013

    Report

    Report Number
    0008031020-2013-00235
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K972323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    DURING OMEGA SURGERY, THE SCREW BROKE AT JUST UNDER THE HEAD. THE SCREW THREAD PART REMAINED IN PATIENT BONE.

    Description of Event or Problem · 1

    DURING OMEGA SURGERY, THE SCREW BROKE AT JUST UNDER THE HEAD. THE SCREW THREAD PART REMAINED IN PATIENT BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330736 CORTEX SCREW S.T. Ø4.5X38MM IMPLANT HRS STRYKER TRAUMA SELZACH Z14732

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other