BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER MIS SCREW SYSTEM

    MDR report key: 4052692 · Received September 2, 2014

    Report

    Report Number
    0002242816-2014-00064
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 6, 2014
    Manufacturer
    EBI, LLC.
    Product Code
    MNI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE PART AND LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PLUG PORTION OF THE SCREW BROKE DURING SURGERY AND THE TIP REMAINS IN THE PATIENT'S BONE. NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534142 CYPHER MIS SCREW SYSTEM CYPHER SCREW MNI EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability