BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 MM DIA X 300MM

    MDR report key: 2462305 · Received February 21, 2012

    Report

    Report Number
    0002242816-2012-00018
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    December 22, 2011
    Report Date
    February 3, 2012
    Manufacturer
    EBI, LLC
    Product Code
    NKB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, "PRECAUTIONS" INCLUDE: HANDLING OF IMPLANTS. IF CONTOURING OF THE ROD IS REQUIRED, AVOID SHARP BENDS AND REVERSE BENDS. AVOID NOTCHING OR SCRATCHING OF THE DEVICE, WHICH COULD INCREASE INTERNAL STRESSES AND LEAD TO EARLY BREAKAGE. ADEQUATE PATIENT INSTRUCTIONS. A PATIENT MUST BE INSTRUCTED ON THE LIMITATIONS OF THE METALLIC IMPLANT, AND SHOULD BE CAUTIONED REGARDING PHYSICAL ACTIVITY AND WEIGHT BEARING OR LOAD BEARING PRIOR TO COMPLETE HEALING. "POSSIBLE ADVERSE EFFECTS" INCLUDE: PAIN, DISCOMFORT, OR ABNORMAL SENSATIONS DUE TO PRESENCE OF THE IMPLANT; REOPERATIONS.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED RODS CONFIRMED THAT THE REPORTED EVENT. MATERIAL AND FRACTURE ANALYSIS OF THE RETURNED RODS DID NOT PROVIDE ANY NEW CONCLUSIVE EVIDENCE AS TO THE CAUSE OF THE REPORTED EVENT. THE DHR WAS REVIEWED AND THERE WERE NO DIMENSIONAL, FUNCTIONAL OR MATERIAL ANOMALIES FOUND IN THE DOCUMENTATION. THE RISK ANALYSIS AND THE DESIGN FMECA WERE ALSO REVIEWED AND IT WAS DETERMINED THAT THE REPORTED EVENT IS ADEQUATELY IDENTIFIED AND REVIEWED. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE ROD BREAKAGE IS EXCESSIVE LOAD FORCES. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS ISSUE IS ADDRESS IN THE PRODUCT IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS CONDUCTED TO REMOVE AND REPLACE FRACTURED RODS. PATIENT OUTCOME: PATIENT REPORTED PAIN PRIOR TO REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5 MM DIA X 300MM 5.5 MM DIA X 300MM NKB EBI, LLC N/A 409610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention