BEUDAMED
    FDA Adverse Event Summary report: N

    NCB CANNULATED SCREW

    MDR report key: 3242620 · Received July 19, 2013

    Report

    Report Number
    9613350-2013-01753
    Date Received
    July 19, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED BY THE MFR FOR INVESTIGATION. AN UPDATED REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING SURGERY WHEN THE PACK WAS BEING OPENED, IT WAS DISCOVERED THAT THE NCB SCREW INSIDE THE PACK WAS NOT CANNULATED. THE SURGERY WAS COMPLETED USING ANOTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338859 NCB CANNULATED SCREW NCB CANNULATED SCREW, 4.00MM DIAMETER HWC ZIMMER GMBH 2713121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other