BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 SYSTEM IMPLANTS

    MDR report key: 3162979 · Received June 11, 2013

    Report

    Report Number
    0002242816-2013-00055
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 15, 2013
    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

    PRODUCT ENROUTE BUT WAS RETURNED YET. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PLUGS CONFIRMED THE REPORTED EVENT. ONE SIDE OF THE PLUG THREADS ARE DAMAGED AND OR SHEARED OFF. THERE IS ALSO DAMAGE ALONG THE PENTALOBE AND ALONG THE POSTERIOR END OF THE PLUG WHERE IT ENGAGES THE ROD. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO DIMENSIONAL, FUNCTIONAL, OR MATERIAL ANOMALIES REPORTED AT INSPECTION. THE THREAD DAMAGE IS OBSERVED TO BE ALIGNED ON ONE SIDE OF THE PLUGS, INDICATING POSSIBLE CROSS-THREADING. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE REPORTED INCIDENT IS EXCESSIVE FORCES ON CROSS-THREADED PLUGS LEADING TO LOSS OF MECHANICAL INTEGRITY AND ULTIMATELY THREAD BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING OPERATIVE PROCEDURE, THREE PLUGS WERE DAMAGED WHILE THE SURGEON DEROTATED THE RODS AND LOCKING THE PLUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262215 POLARIS 5.5 SYSTEM IMPLANTS DEROTATION PLUG - 5.5 KWP EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1