BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERBODY SYSTEM

    MDR report key: 6337999 · Received February 16, 2017

    Report

    Report Number
    2090010-2017-00002
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    December 18, 2016
    Report Date
    February 1, 2017
    Manufacturer
    SEASPINE, INC
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO REVISION SURGERY IS PLANNED. SURGEON HAS ELECTED TO MONITOR PATIENT AT THIS TIME. THERE IS NO EVIDENCE THAT THE DEVICE MALFUNCTIONED. IT IS UNKNOWN WHAT CAUSED THE DYSESTHESIA IN THE LEGS. IT IS UNKNOWN IF THE PATIENT FOLLOWED POST-OPERATIVE INSTRUCTIONS. PATIENT SHOULD BE CAUTIONED AGAINST EARLY WEIGHT BEARING AND PREMATURE AMBULATION THAT COULD LEAD TO LOOSENING AND/OR FAILURE OF THE FIXATORS OR LOSS OF REDUCTION. IT IS UNKNOWN WHICH CONCOMITANT DEVICE (IF ANY) OR PART OF THE INTERBODY FUSION SURGICAL PROCEDURE (IF ANY) HAS CAUSED OR CONTRIBUTED TO THIS EVENT, AND NO CONCLUSION CAN BE DRAWN. LABELING, WARNING AND PRECAUTIONS: PROCEDURES INVOLVING BONE GRAFTING CAN PRODUCE HIGHLY VARIABLE RESULTS. SIGNIFICANT VASCULAR OR NEUROLOGICAL IMPAIRMENT PROXIMAL TO THE GRAFT SITE. SEVERE VASCULAR OR NEUROLOGICAL DISEASE. METABOLIC OR SYSTEMIC BONE DISORDERS THAT AFFECT BONE OR WOUND HEALING. SEVERE DEGENERATIVE BONE DISEASE. UNCOOPERATIVE PATIENTS WHO WILL NOT OR CANNOT FOLLOW POSTOPERATIVE INSTRUCTIONS, INCLUDING INDIVIDUALS WHO ABUSE DRUGS AND/OR ALCOHOL. IT IS NOT INTENDED TO REPLACE OR CHANGE STANDARD PROCEDURES FOR TREATMENT OF BONE DEFECTS INVOLVING BONE GRAFTING AND FIXATION. DOES NOT POSSESS SUFFICIENT MECHANICAL STRENGTH TO SUPPORT THE REDUCTION OF A GRAFT SITE PRIOR TO TISSUE IN-GROWTH. THEREFORE ANATOMICAL REDUCTION AND RIGID FIXATION IN ALL PLANES SHOULD BE OBTAINED INDEPENDENTLY.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A (B)(6) YEAR OLD FEMALE UNDERWENT A ONE LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 INVOLVING CASCADIA INTERBODY (K2M INC.), POSTERIOR FIXATION, AUTOGRAFT AND BONE VOID GRAFTING BIOLOGIC DEVICES. FIRST FOLLOW UP, SEVEN TO TEN DAYS POSTOPERATIVELY, THE PATIENT REPORTED DYSESTHESIA IN THEIR LEG. SURGEON REPORTED THERE WAS NO PEDICLE BREACH, NO NERVE ROOT SWELLING AND NO EMG CHANGES. A SIX WEEK FOLLOW UP, THE SURGEON DETERMINED THE PATIENT WAS PROGRESSING, BUT CONTINUING TO EXPERIENCE PAIN IN THE LEG. AT THIS TIME, NO MEDICAL INTERVENTION/REVISION SURGERY IS PLANNED. SURGEON WILL CONTINUE TO MONITOR PATIENT IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118270 INTERBODY SYSTEM VERTEBRAL BODY PROSTHESIS PRODUCT, PRODUCT CODE: MAX MAX SEASPINE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR CASCADIA INTERBODY, K2M INC.| EVO3 PUTTY 10CC| TRINITY ELITE MEDIUM