BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFIX LR

    MDR report key: 7040879 · Received November 16, 2017

    Report

    Report Number
    MW5073390
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    August 1, 2004
    Report Date
    November 15, 2017
    Manufacturer
    DEPUY-SYNTHES
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    LITERATURE REPORTS FROM (B)(6) 2004 UNTIL (B)(6) 2007, 95 PTS (21 DOUBLE-LEVEL AND 74 SINGLE-LEVEL) WITH DEGENERATIVE DISK DISEASE FROM L3-S1 WERE OPERATED BY A SINGLE SURGEON. THE NUMBER OF REOPERATIONS WAS COUNTED, 26 PTS WERE REOPERATED AFTER A MEDIAN PERIOD OF 17.6 MONTHS (RANGE 6.7-46.9) OF THE INITIAL SURGERY. OF THE 26 PTS, 23 PTS (18 SINGLE-LEVEL AND 5 DOUBLE-LEVEL) WERE REOPERATED FOR SYMPTOMATIC PSEUDARTHROSIS. A HIGH NUMBER OF REOPERATIONS AFTER AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE WITH THE SYNFIX-LR CAGE WERE FOUND, MAINLY BECAUSE OF SYMPTOMATIC PSEUDARTHROSIS. THE ABSENCE OF POSTERIOR FIXATION IN COMBINATION WITH LOWER STIFFNESS AND THE HYDROPHOBIC CHARACTERISTICS OF PEEK PROBABLY LEAD TO INSUFFICIENT INITIAL STABILITY, CREATING SUBOPTIMAL CONDITIONS FOR BONY BRIDGING, AND THUS SOLID FUSION. THE PROPOSED EASE OF THE EVAL OF RADIOLOGIC FUSION COULD NOT BE SUPPORTED. CLINICIANS SHOULD BE ALERT ON PSEUDARTHROSIS WHEN PTS TREATED WITH THE SYNFIX-LR CAGE PRESENTED WITH PERSISTED OR AGGRAVATED COMPLAINTS SCHIMMEL, JANNEKE JP, ET AL. "PEEK CAGES IN LUMBAR FUSION: MID-TERM CLINICAL OUTCOME AND RADIOLOGIC-FUSION." CLINICAL SPINE SURGERY 29.5 (2016): E252-E258.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815548 SYNFIX LR INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION OVD DEPUY-SYNTHES 03.802

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R| S