BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERX PPS SYSTEM

    MDR report key: 3905052 · Received June 10, 2014

    Report

    Report Number
    2031966-2014-00038
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 10, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K090981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NUVASIVE REFERENCE (B)(4). NO INITIAL SURGERY DATE WAS PROVIDED IN ORDER TO DETERMINE THE DURATION OF IMPLANTATION PRIOR TO DEVICE FAILURE. THE PATIENT'S ACTIVITY LEVEL AND ADHERENCE TO POST-OPERATIVE CARE INSTRUCTIONS ARE ALSO UNKNOWN. PRODUCT INVOLVED HAS NOT BEEN RETURNED FOR EVAL. NO ROOT CAUSE HAS BEEN IDENTIFIED. SHOULD FURTHER RELEVANT INFORMATION BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT TWO SCREWS ON THE RIGHT SIDE OF L5 AND S1 FRACTURED MID-SHAFT POST-OPERATIVELY. THE SCREWS HAD TO BE REMOVED AND REPLACED WITHIN THE LAST 6 WEEKS. INITIAL SURGERY DATE, PATIENT DEMOGRAPHIC INFORMATION AND RADIOGRAPHS WERE NOT PROVIDED TO CONFIRM THE REPORTED EVENT. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342268 SPHERX PPS SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS NKB NUVASIVE, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention