BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERX DEFORMITY SYSTEM

    MDR report key: 1972641 · Received January 20, 2011

    Report

    Report Number
    2031966-2011-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    September 21, 2010
    Report Date
    January 19, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K091502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD THE PRODUCT BE RETURNED, A MORE DETAILED REVIEW WILL BE UNDERTAKEN AND ANY RELEVANT INFO WILL BE REPORTED. LABELING REVIEW NOTES THE FOLLOWING: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADD'L SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY." "THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS." "METALLIC INTERNAL FIXATION DEVICES CANNOT WITHSTAND THE ACTIVITY LEVELS AND/OR LOADS EQUAL TO THOSE PLACED ON NORMAL, HEALTHY BONE. THESE DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF FULL WEIGHT OR LOAD BEARING ALONE." "THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOAD ASSOCIATED WITH DELAYED UNION OR NON-UNION. 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 PT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT."

    Description of Event or Problem · 1

    THE PT HAD RECEIVED A PEDICLE SCREW PLACEMENT FOR SPONDYLOLISTHESIS AT L5-S1 ON (B)(6) 2010. SUBSEQUENTLY, THE RIGHT S1 SCREW WAS NOTED TO BE BROKEN ON (B)(6) 2010. THE PT WAS ASYMPTOMATIC AND REVISION WAS NOT PLANNED. ON (B)(6) 2010, LEFT S1 SCREW BROKE AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2010. THE REMOVED PRODUCT WAS GIVEN TO THE PT BY THE SURGEON AND IS NOT EXPECTED TO BE RETURNED FOR EVAL. THERE WERE NO REPORTED ANATOMICAL ISSUES NOR FAILURE TO COMPLY WITH POST-SURGICAL CARE INSTRUCTIONS. THE PT WAS REPORTED TO BE DOING WELL FOLLOWING THE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention