BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE

    MDR report key: 2771729 · Received September 28, 2012

    Report

    Report Number
    9616696-2012-00253
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 4, 2012
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS MULTI-FACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A MEDWATCH REPORT THAT DURING A SURGICAL PROCEDURE THE BLADE BROKE AT THE MOUNT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE GFA STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK