BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPHERX DEFORMITY SYSTEM

    MDR report key: 3601631 · Received January 17, 2014

    Report

    Report Number
    2031966-2013-00095
    Event Type
    Other
    Date Received
    January 17, 2014
    Date of Event
    September 26, 2013
    Report Date
    January 17, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K092287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCARDED BY HOSPITAL. (B)(4). REVIEW OF THE RADIOGRAPHS CONFIRM THE BONE SCREW PULLOUTS AT L4. REVISION OCCURRED ON (B)(6) 2013, TO REPLACE THE PEDICLE SCREWS WITH LARGER SCREWS FOR BETTER BONE PURCHASE. NO PRODUCT EVALUATION CAN BE COMPLETED AT THIS TIME AS THE IMPLANTS WERE DISCARDED BY USER FACILITY. THOUGH THE PATIENT HAD LESS THAN NORMAL BONE QUALITY, SHE WAS NOT OSTEOPOROTIC. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED; HOWEVER, BONE QUALITY MAY BE A CONTRIBUTING FACTOR. REVIEW OF LABELING NOTES: WARNINGS CAUTIONS AND PRECAUTIONS - PRODUCT LABELING INDICATES "POTENTIAL RISKS IDENTIFIED WITH THE USER OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY."

    Description of Event or Problem · 1

    THE SPHERX DEFORMITY PEDICLE SCREWS REPORTEDLY PULLED OUT OF BONE POST-OPERATIVELY. THE INITIAL TRANSFORAMINAL LUMBAR INTERBODY FUSION WAS PERFORMED AT L4-L5 ON (B)(6) 2013 WITH POSTERIOR CONSTRUCT FROM L4-S1 BILATERALLY. PATIENT WAS DOING VERY WELL IMMEDIATELY. PATIENT THEN HAD INCREASING PAIN ONE WEEK POST OPERATIVELY. ON (B)(6) 2013, IT WAS DISCOVERED THAT THE PEDICLE BONE SCREWS AT L4 HAD PULLED OUT BILATERALLY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013, IN WHICH LARGER BONE SCREWS WERE PLACED IN THE L4 PEDICLE, CONSTRUCT EXTENDED WITH ADDITIONAL SCREWS TO THE L3 VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44544 SPHERX DEFORMITY SYSTEM SPINAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC. 8456045

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR