BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIUS OCT POSTERIOR SPINAL SYSTEM IMPLANTS AND INSTRUMENTS

    MDR report key: 2462244 · Received February 21, 2012

    Report

    Report Number
    0002242816-2012-00017
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE REPORTED EVENT. THE PENTALOBE TIP ON THE DRIVER WAS BROKEN OFF. THE DHR WAS REVIEWED AND THERE WERE NO DIMENSIONAL, FUNCTIONAL OR MATERIAL ANOMALIES FOUND IN THE DOCUMENTATION THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE DRIVER DAMAGE IS EXCESSIVE TORQUE AND DEFLECTION FORCES WITH THE DEFLECTION FORCES CAUSING MOST OF THE DAMAGE AS EVIDENCED BY THE ANGLED BREAKAGE. WITHOUT FURTHER INFORMATION, NO EXACT CONCLUSION COULD BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INSTRUMENT FRACTURED DURING USE. THE TIP OF THE INSTRUMENT REMAINS IMPLANTED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTIUS OCT POSTERIOR SPINAL SYSTEM IMPLANTS AND INSTRUMENTS 5 LOBE SCREW DRIVER KWP EBI, LLC N/A 673197

    Patients

    Seq Age Sex Outcome Treatment
    1