BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH IMPLANT SYSTEM

    MDR report key: 10910701 · Received November 26, 2020

    Report

    Report Number
    1030489-2020-01702
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    August 25, 2020
    Report Date
    November 26, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: 35.85 YRS (17-72 YRS) MEAN AGE OF 7 PATIENTS. SEX: FEMALE (ALL 7 PATIENTS ARE FEMALE). COUNTRY: FRANCE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: MAXIME RIVOLLIER, BENOIT MARLIER, JEAN-CHARLES KLEIBER, CHRISTOPHE EAP, CLAUDE-FABIEN LITRE. SURGICAL TREATMENT OF HIGH-GRADE SPONDYLOLISTHESIS: TECHNIQUE AND RESULTS. JOURNAL OF ORTHOPAEDICS 22 (2020) 383¿389. A RETROSPECTIVE STUDY. HTTPS://DOI.ORG/10.1 016/J.JOR.2020.08.015. EVENT SUMMARY: THIS STUDY IS A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SURGERY BETWEEN 2016 AND 2018. SEVEN CONSECUTIVE ADOLESCENTS AND ADULTS PATIENTS (MEAN: 35.85 YRS AND MEDIAN: 37 [17¿72 YEARS]) UNDERWENT SURGERY BETWEEN 2016 AND 2018. THIS RETROSPECTIVE STUDY WAS PERFORMED IN REIMS UNIVERSITY HOSPITAL (FRANCE). INDICATIONS FOR SURGICAL INTERVENTION IN PATIENTS WITH HIGH GRADE SPONDYLOLISTHESIS INCLUDE CONTINUED PAIN, PROGRESSION OF NEUROLOGIC SYMPTOM, OR PROGRESSION OF THE SLIP (EVEN IF THE SLIPPAGE INCREASING DURING ADULTHOOD IS UNCOMMON). ALL THE CASES HAD GRADE 3 OR 4. EVERY PATIENT IS FEMALE WITH ONE PEDIATRIC (A YOUNG GIRL OF 16 YEARS OLD WITH GRADE IV SPONDYLOLISTHESIS). THE SURGICAL METHOD INVOLVED SPECIFIC INSTALLATION FOR DEFORMITY REDUCTION, PEDICLE SCREW FIXATION, CORRECTION OF LUMBOSACRAL KYPHOSIS WITH A SPECIFIC DISTRACTION MANEUVER, WIDE DECOMPRESSION, GRADUAL REDUCTION OF THE DEFORMITY, AND SOMETIMES MAINTENANCE OF THE REDUCTION WITH INTERBODY FUSION. PATIENTS WERE CHECKED OUT AT 2, 6 AND 12 MONTHS AND YEARLY AFTER THE PROCEDURE. CLINICAL, RADIOLOGICAL, VISUAL ANALOGIC SCALE (VAS) AND OSWESTRY DISABILITY INDEX (ODI) OUTCOMES MEASURES WERE COLLECTED. SEVEN PATIENTS WITH HIGH-GRADE SPONDYLOLISTHESIS AT L5-S1 WERE OPERATED USING THIS PROGRESSIVE REDUCTION TECHNIQUE, REPRESENTING 2 PATIENTS GRADE III (28%), 4 PATIENTS GRADE IV (57%) AND ONE PATIENT GRADE V (15%). ALL PROCEDURE WAS PERFORMED IN A SINGLE OPERATION USING A POSTERIOR APPROACH. THE MEDIAN AGE WAS 37 YEARS OLD. ALL PATIENTS WERE UPRIGHT ON THE SECOND POSTOPERATIVE DAY. A VARIABLE REAMER WAS SEQUENTIALLY DRILLED OVER THE GUIDEWIRE TO 1 MM LESS THAN THE DIAMETER OF THE TITANIUM MESH (PYRAMESH¿, MEDTRONIC®, MINNEAPOLIS, USA). THE MESH WAS MEASURED AND CUT, BEFORE DRIVEN INTO POSITION ACROSS L5-S1 DISC. IT WAS BEFOREHAND FILLED WITH CANCELLOUS BONE GRAFT, OR BONE GRAFT BANK, OR BOTH. ONLY ONE STRUT WAS PLACED. A TOTAL OF 4 (57%) PATIENTS BENEFITED FROM THIS PROCEDURE (ONLY IN 4 PATIENTS MEDTRONIC DEVICE WAS IMPLANTED). REPORTED EVENTS: ONLY ONE PATIENT (A YOUNG GIRL OF (B)(6) YEARS OLD WITH GRADE IV SPONDYLOLISTHESIS) PRESENTED A LOW BACK PAIN AT ONE YEAR OF FOLLOW-UP. SHE HAD INITIALLY L4-L5-S1 ARTHRODESIS WITH TRANS-SACRAL FIXATION STRUT. RADIOGRAPHIES AND CT-SCANNER SHOWED A LACK OF FUSION AND PSEUDARTHROSIS WITH A FAILURE OF TRANS-VERTEBRAL TRANS-SACRAL STRUT. FIXATION WAS REVISED AFTER 18 MONTHS OF FOLLOW-UP: IT WAS DECIDED AN EXTENSION OF CONSTRUCT, WITH S2 SCREWS AND ILIAC SCREWS IMPLANTATION. SINCE, HER BACK PAIN DECREASED. ONE PATIENT PRESENTED PERSISTENT L5 SCIATALGIA. ONE INTRAOPERATIVE COMPLICATION WITH PER OPERATIVE BLEEDING AND AVOIDING IMPLEMENTATION OF THE TRANS-VERTEBRAL TRANS-SACRAL DEVICE. ONLY ONE PATIENT DID NOT PRESENT A SOLID FUSION AT THE 6 MONTHS FOLLOW-UP VISIT. THE RADIOGRAPHIC PARAMETER MEASURED WAS THE LUMBOSACRAL ANGLE (LSA). THE MEDIAN PREOPERATIVE DEGREE OF SLIP WAS 76¿[59; 85] AND REDUCED TO 94¿[76; 104], WITH THE MEYERDING GRADE OF 2 CASES STABLES AFTER SURGERY, 3 CASES WITH LOSS OF TWO RANKS AND 2 CASES WITH LOSS OF ONE RANK. THE RADIOLOGICAL PARAMETERS SHOWED STATISTICALLY SIGNIFICANT DIFFERENCE (P = 0.002) POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373557 PYRAMESH IMPLANT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_CG_PYRMH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention