BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPHERX DEFORMITY SYSTEM

    MDR report key: 3601630 · Received January 17, 2014

    Report

    Report Number
    2031966-2013-00093
    Event Type
    Other
    Date Received
    January 17, 2014
    Date of Event
    September 19, 2013
    Report Date
    January 17, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MCV
    PMA / PMN Number
    K092287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BONE SCREW PULL OUT. REVIEW OF THE RADIOGRAPH CONFIRM THE BONE SCREWS PULLOUTS FROM THE L4 PEDICLE. FIRST REVISION OCCURRED ON (B)(6) 2013 TO REPLACE THE L4 PEDICLE SCREWS WITH LARGER SCREWS FOR BETTER BONE PURCHASE. THE CONSTRUCT WAS EXTENDED CRANIALLY TO L3 WITH ADDITIONAL SCREWS. NO PRODUCT EVALUATION CAN BE COMPLETED AT THIS TIME AS THE IMPLANTS WERE DISCARDED BY USER FACILITY. THE PATIENT HAD POOR BONE INTEGRITY, WHICH CONTINUED TO DEGRADE. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED, NO CONCLUSION CAN BE DRAWN. HOWEVER, BONE QUALITY MAY BE A CONTRIBUTING FACTOR. REVIEW OF LABELING NOTES; "CONTRA-INDICATIONS INCLUDE BUT ARE NOT LIMITED TO...5. PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY." WARNING, CAUTIONS AND PRECAUTIONS - PRODUCT LABELING INDICATES "POTENTIAL RISKS IDENTIFIED WITH THE USE 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 POSTERIOR LUMBAR FUSION WAS PERFORMED ON (B)(6) 2013 INVOLVING A CONSTRUCT FROM L4-S1 BILATERALLY. ON (B)(6) 2013 DURING ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT THE PEDICLE BONE SCREWS AT L4 HAD PULLED OUT BILATERALLY. THE PATIENT WAS ASYMPTOMATIC. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 AND LARGER PEDICLE SCREW WERE PLACE. THE CONSTRUCT WAS EXTENDED TO THE L3 VERTEBRAL BODY AND A TLIF WAS PERFORMED AT L4-L5. THE PATIENT HAD POOR BONE INTEGRITY, WHICH CONTINUED TO DEGRADE. SECOND REVISION OCCURRED ON (B)(6) 2013 AND IS FILED UNDER 2031966-2013-00094.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44675 SPHERX DEFORMITY SYSTEM SPINAL PEDICLE SCREW SYSTEM MCV NUVASIVE, INC. 8456045

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR