BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLORADO 2? SPINAL SYSTEM

    MDR report key: 3173689 · Received June 17, 2013

    Report

    Report Number
    1030489-2013-02339
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    August 27, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MNH
    PMA / PMN Number
    K991031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF RADIOGRAPHIC IMAGES SHOW SEVERAL LATERAL X-RAYS OF A CONSTRUCT FROM L4 TO THE SACRUM. THERE IS A GRADE ONE SPONDYLOLISTHESIS AT L4. ONE OF THE S1 SCREWS HAS BROKEN WITHIN THE PEDICLE. S1 SCREWS WERE NOT UPSIZED AND NO ANTERIOR COLUMN SUPPORT (PLIF, TLIF OR ALIF) WAS PROVIDED TO RELIEVE LUMBOSACRAL STRESS. THIS PLACED THE CONSTRUCT AT HIGH RISK FOR FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT A PEDICLE SCREW WAS BROKEN. X-RAY CONFIRMS SCREW BREAKAGE. A REVISION IS PLANNED TO REMOVE THE BROKEN SCREW. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274499 COLORADO 2? SPINAL SYSTEM ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION MNH MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR