BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5965890 · Received September 21, 2016

    Report

    Report Number
    3004774118-2016-00077
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    July 8, 2016
    Report Date
    August 22, 2016
    Manufacturer
    K2M, INC.
    Product Code
    HTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08/22/2016 K2M, INC. RECEIVED A COPY OF THE USER REPORT (B)(4) FROM (B)(6). K2M, INC. HAS BEEN UNABLE TO DETERMINE THE PRODUCT TO WHICH THIS REPORT PERTAINS, AS THE REPORT DID NOT PROVIDE A PART OR LOT NUMBER AND THE PRODUCT HAS NOT BEEN RETURNED. WE HAVE MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER IN AN EFFORT TO OBTAIN FURTHER IDENTIFYING INFORMATION REGARDING THE PRODUCT, TO NO AVAIL. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON 08/22/2016 K2M, INC. RECEIVED A COPY OF THE USER SUBMITTED REPORT WHICH STATED: EVENT DESC: DOUBLE BLADED KNIFE HANDLE USED TO DISSECT THROUGH SOFT TISSUE AND BONE. SMALL PORTION OF TIP BROKE OFF AND WAS NON-RETRIEVABLE. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619585 UNKNOWN UNKNOWN HTS K2M, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR