BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERX DEFORMITY SYSTEM

    MDR report key: 2051332 · Received April 1, 2011

    Report

    Report Number
    2031966-2011-00014
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Report Date
    March 30, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K091502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR FAILURE INVESTIGATION AND NO ADDITIONAL EVALUATION HAS BEEN POSSIBLE; HOWEVER, ANALYSIS OF SIMILAR DEVICES IS IN PROCESS. THE FAILURE MODE HAS BEEN REPLICATED IN A LABORATORY SETTING; HOWEVER, CONFIRMATION OF THE ROOT CAUSE OF THIS EVENT IS UNKNOWN AT THIS TIME. IDENTIFICATION OF THE ROOT CAUSE(S) FOR THIS FAILURE MODE ARE PENDING. 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 AND VASCULAR OR VISCERAL INJURY." A FOLLOW-UP REPORT WILL BE FILED WHEN NEW RELEVANT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN ARMADA DEFORMITY STABILIZATION SURGERY FOR SCOLIOSIS CORRECTION AT THE T2-L1 SPINE LEVELS ON (B)(6) 2010. A SCREW TULIP SEPARATION WAS REPORTED AT THE T11 VERTEBRAL BODY DURING FOLLOW-UP EVALUATION. THERE WAS NO INJURY REPORTED AND REVISION SURGERY HAS NOT OCCURRED. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC. THERE WERE NO KNOWN ANATOMICAL ISSUES THAT MAY HAVE CONTRIBUTED TO THE PROBLEM. BONE INTEGRITY WAS REPORTED TO BE GOOD AND PATIENT COMPLIANCE WITH POST-OPERATIVE INSTRUCTIONS WAS ALSO REPORTED TO BE APPROPRIATE FOLLOWING 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