BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPHERX DEFORMITY SYSTEM

    MDR report key: 3601632 · Received January 17, 2014

    Report

    Report Number
    2031966-2013-00092
    Event Type
    Other
    Date Received
    January 17, 2014
    Date of Event
    November 15, 2013
    Report Date
    January 17, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K092287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IN-SITU. REVIEW OF THE RADIOGRAPHS CONFIRM THE BONE AROUND THE PEDICLE BONE SCREW HAS A REDUCTION OF BONE DENSITY. THERE APPEARS TO BE A DECREASE IN BONE HEALING, BUT PATIENT IS REPORTEDLY ASYMPTOMATIC. CURRENTLY THERE IS NO PLAN FOR REVISION SURGERY. THE SURGEON WILL CONTINUE TO MONITOR. NO PRODUCT EVALUATION CAN BE COMPLETED AT THIS TIME AS THE IMPLANTS REMAIN IN-SITU. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED, NO CONCLUSION CAN BE DRAWN. REVIEW OF LABELING NOTES; 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." "INTERNAL FIXATION APPLIANCES ARE LOAD SHARING DEVICES THAT HOLD BONY STRUCTURES IN ALIGNMENT UNTIL HEALING OCCURS. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND, OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT."

    Description of Event or Problem · 1

    THE SPHERX DEFORMITY PEDICLE SCREWS REPORTEDLY WERE UNSUCCESSFUL AT OSSEOINTEGRATING POST OPERATIVELY. THE INITIAL POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED ON (B)(6) 2013 INVOLVING A CONSTRUCT FROM L4-S1 BILATERALLY. THE PATIENT WAS SUCCESSFULLY FUSING INITIALLY. ON (B)(6) 2013, DURING ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT THE BONE AROUND THE PEDICLE SCREWS AT L4 WAS BECOMING RADIOLUCENT. THE PATIENT WAS ASYMPTOMATIC. THERE IS NO CURRENT PLANS FOR REVISION AND THE SURGEON IS CONTINUING TO MONITOR. PATIENT'S ACTIVITY LEVEL IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT COMPLIED WITH POST-OPERATIVE CARE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44676 SPHERX DEFORMITY SYSTEM SPINAL PEDICLE SCREW SYSTEM KWQ NUVASIVE, INC. 8456050

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR