BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM IMPLANTS AND INSTRUMENTS

    MDR report key: 2510753 · Received March 30, 2012

    Report

    Report Number
    0002242816-2012-00028
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 5, 2012
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED INSTRUMENTS CONFIRMED THAT THE REPORTED EVENT. THE THREADED END OF THE TWO OUTER SLEEVES ARE FRACTURED AT THE TIP. A SECTION OF THE BROKEN TIP IS STUCK ON THE SCREW HEAD ALONG WITH THE ATTACHED SHAFT. ALL FOUR ITEMS WERE RECEIVED WITH THE COMPLAINT. THE MANUFACTURING RECORDS FOR THE OUTER SLEEVES WERE REVIEWED FOUND TO HAVE NO DIMENSIONAL, FUNCTIONAL OR MATERIAL ANOMALIES IN THE DOCUMENTATION. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE REPORTED EVENT IS EXCESSIVE TORQUE FORCES DURING USAGE OR HANDLING OF THE INSTRUMENTS. UNDER THOSE CONDITIONS, THE SHAFT THREAD WOULD BE THE REGION OF THE INSTRUMENT WITH THE SMALLEST CROSS-SECTIONAL AREA AND MORE PRONE TO BREAKAGE.

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 3 MDRS INVOLVED IN THE SAME EVENT. PLEASE SEE MDR NUMBERS: 2242816-2012-00028, 2242816-2012-00029, 2242816-2012-00030. PER THE INSTRUCTIONS FOR USE, "POSSIBLE ADVERSE EFFECTS" INCLUDE BENDING, FRACTURE, LOOSENING OR MIGRATION OF THE IMPLANT PAIN, DISCOMFORT, OR ABNORMAL SENSATIONS DUE TO PRESENCE OF THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER SLEEVE OF TWO SCREW INSERTERS FRACTURED DURING SURGERY. THREADS FROM ONE OF THE OUTER SLEEVES CANNOT BE FOUND.PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM IMPLANTS AND INSTRUMENTS 6.5MMX45MM MULTIAXIAL SCREW KWP EBI, LLC N/A J2521572B

    Patients

    Seq Age Sex Outcome Treatment
    1