BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 1628511 · Received March 11, 2010

    Report

    Report Number
    2242816-2010-00034
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Report Date
    February 10, 2010
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: 2008.EXPLANT DATE: (B)(6) 2010.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT, DURING AN ARRAY REMOVAL, THE TULIP HEAD SNAPPED OFF OF AN ARRAY PEDICLE SCREW. THE PATIENT RETAINED THE FRACTURED SCREW. PATIENT OUTCOME: NO ADVERSE AFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM ARRAY PEDICLE SCREW MNI EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1