BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 3930059 · Received July 11, 2014

    Report

    Report Number
    0008010177-2014-00177
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION, WITHIN THE CONTEXT OF NEW INFORMATION, THAT IN THIS SURGERY ONLY TWO UNKNOWN SCREW WERE INVOLVED BESIDE THE EMERGENCY BLADE. THE MENTIONED THIRD SCREW DOES BELONG TO THE (B)(6), WHERE THE COMPLAINT 561934 HAS BEEN OPENED FOR. THIS SEEMS TO BE A MISUNDERSTANDING BETWEEN THE COMPLAINT MANAGEMENT CENTER AND THE COMPLAINT INTAKE CENTER. THE INVESTIGATION RELATED TO THIS PRODUCT WAS THEREFORE A DUPLICATE AND HAS BEEN CANCELLED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THE FOLLOWING INFORMATION ON- THREE SCREWS WERE TRYING TO BE REMOVED WITH THE EMERGENCY REMOVAL BLADE, BUT IT DESTROYED THE SCREWS. THIS CAUSED A ONE HOUR DELAY IN SURGERY. THE SCREWS WERE LEFT IN.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THE FOLLOWING INFORMATION ON- THREE SCREWS WERE TRYING TO BE REMOVED WITH THE EMERGENCY REMOVAL BLADE, BUT IT DESTROYED THE SCREWS. THIS CAUSED A ONE HOUR DELAY IN SURGERY. THE SCREWS WERE LEFT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406678 UNKNOWN_FRO_PRODUCT IMPLANT HWC STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other