BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-LOK POLYAXIAL SCREW

    MDR report key: 3258863 · Received July 30, 2013

    Report

    Report Number
    3005739886-2013-00024
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. AS NO PART OR LOT NUMBERS WERE AVAILABLE, REVIEW OF THE MANUFACTURING RECORDS AND PART NUMBER SPECIFIC COMPLAINT HISTORY WAS NOT POSSIBLE. REVIEW OF COMPLAINT HISTORY FOR THE SLPXXXX FAMILY OF S-LOK PEDICLE SCREWS DID NOT IDENTIFY A TREND FOR REPORTS OF FRACTURE. ASSOCIATED INSTRUCTIONS FOR USE (IFU) SPINAL USA S-LOK PEDICLE SCREW SYSTEM UTILIZING SURE LOK TECHNOLOGY (LBL-IFU-004) STATES UNDER PRECAUTIONS: "3. FRACTURE/MECHANICAL FAILURE OF THE DEVICE," UNDER POSSIBLE ADVERSE EVENTS: "7. DEVICE COMPONENT FRACTURE," AND UNDER WARNINGS: "3. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION..."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT LUMBAR-SACRUM FIXATION ON (B)(6) 2012, TO ADDRESS SPONDYLOLISTHESIS L4-L5 AND DDD. PT REPORTED A RELIEVED LUMBAR PAIN AND RADICULOPATHY. SIX MONTHS POST OPERATIVE, PT PRESENTED WITH PAIN THAT EXACERBATED WITH FLEXION/EXTENSION MOVEMENTS. CT SCAN WAS PERFORMED AND IDENTIFIED A SCREW IN L5 APPEARS TO BE FRACTURED. REVISION SURGERY IS PLANNED BUT HAS NOT BEEN PERFORMED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355634 S-LOK POLYAXIAL SCREW PEDICLE SCREW SPINAL SYSTEM MNI SPINAL USA, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention