BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NILE ALTERNATIVE FIXATION SYSTEM

    MDR report key: 6101512 · Received November 15, 2016

    Report

    Report Number
    3004774118-2016-00095
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 16, 2016
    Manufacturer
    K2M, INC.
    Product Code
    OWI
    UDI-DI
    10888857157682
    PMA / PMN Number
    K143350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE CLAMP WAS DISPOSED OF AT THE HOSPITAL, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. THE DIFFICULTY WITH THE NILE CLAMP IS CONSISTENT WITH IMPROPER TECHNIQUE. TIGHTENING A SET SCREW ON A BAND AND REPOSITIONING CAN CAUSE STRESS RISERS IN THE BAND. WHILE THE IMPLANT WAS NOT RETURNED, A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS REVEALED NO ADDITIONAL INFORMATION. HOSPITAL DISPOSED OF DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A SURGERY TOOK PLACE ON (B)(6) 2016 IN WHICH A NILE CLAMP DID NOT WORK AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753552 NILE ALTERNATIVE FIXATION SYSTEM BONE FIXATION CERCLAGE OWI K2M, INC. UNKNOWN 10888857157682

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR (B)(4) LOT UNKNOWN| (B)(4) LOT UNKNOWN