BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINOUS PROCESS PLATE SYSTEM

    MDR report key: 6977789 · Received October 25, 2017

    Report

    Report Number
    2031966-2017-00150
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 29, 2017
    Report Date
    January 19, 2018
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    UDI-DI
    00887517062345
    PMA / PMN Number
    K073278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO RADIOGRAPHS, PHOTOGRAPH OR PRODUCT WERE PROVIDED TO CONFIRM THE REPORTED EVENT. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME, HOWEVER DUE TO THE LENGTH OF TIME FROM SURGERY TO INFECTION AS WELL AS CONVEYED CULTURE RESULTS SUGGEST THAT THE INFECTION WAS COMMUNITY ACQUIRED. LABELING REVIEW: ...ALL NON-STERILE PARTS SHOULD BE CLEANED AND STERILIZED BEFORE USE." "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS KNOWN TO OCCUR INCLUDE: EARLY OR LATE INFECTION WHICH MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES." NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORTED SUBMITTED TO UPDATE SECTION BASED ON INFORMATION RECEIVED. CULTURE RESULTS RETURNED NEGATIVE. NO INFECTION WAS DETECTED, NO PRODUCT MALFUNCTION. PATIENT IS REPORTED TO BE DOING WELL.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION PROCEDURE AT L5-S1 LEVELS WITH NO KNOWN ISSUES. DURING A FOLLOW UP IT WAS OBSERVED THAT THE INCISION SITE WAS NOT HEALING. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE TO REMOVE THE IMPLANTS WITHOUT REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756170 SPINOUS PROCESS PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP NUVASIVE, INC. 7577035 00887517062345

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention