BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2112413 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00661
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND 2 POSTOPERATIVE FILMS OF SCOLIOSIS CONSTRUCT WITH MULTIPLE PEDICLE SCREWS T2-SACRUM. SECOND SET OF FILMS VERIFIES RIGHT SIDED ILIAC EXTENDER HAS LOOSENED BOTH ON THE ROD AND THE ILIAC BOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY. IT WAS REPORTED THAT SOMETIME POST-OP THE PATIENT LOST FIXATION IN THE PELVIC AREA AND WAS EXPERIENCING MINIMAL PAIN. X-RAYS FOUND THAT THE CONNECTOR HAD DISENGAGED FROM THE ILIAC BOLT AND FROM THE ROD. NO REVISION HAS BEEN SCHEDULED. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1