BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERPOS PLS

    MDR report key: 2011906 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00017
    Event Type
    Other
    Date Received
    February 28, 2011
    Date of Event
    January 18, 2008
    Report Date
    February 10, 2011
    Manufacturer
    INTERVENTIONAL SPINE INC.
    Product Code
    MRW
    PMA / PMN Number
    K062391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: REVIEW OF CT IMAGES ON CD PROVIDED BY SURGEON. RECENT PLACEMENT OF TRUFUSE DEVICES BILATERALLY AT L5-S1 THAT WERE SUBSEQUENTLY REPLACED WITH BILATERAL PERPOS DEVICES. CT SCANS DATED (B)(6)-2008. COMPARABLE AXIAL, SAGITTAL AND CORONAL IMAGES FROM BOTH SCANS WERE REVIEWED AND COMPARED. PERPOS DEVICES ARE PRESENT BILATERALLY AT L5-S1. EACH DEVICE TRAVERSES THE FACET JOINT AT L5-S1 AND ENTERS THE PEDICLE OF THE SACRAL ALA. THE COLLAR OF EACH DEVICE IS IMMEDIATELY ADJACENT TO THE L5 IAP. THE POSITION OF EACH DEVICE IS UNCHANGED ON THE TWO EXAMS. THE TIP POSITION OF THE RIGHT AND LEFT DEVICE ARE DIFFERENT FROM EACH OTHER BUT STABLE ON THE TWO EXAMS. ON THE LEFT, THERE IS A FOREIGN BODY IN THE SOFT TISSUES ADJACENT TO THE L5-S1 FACET JOINT. THE DENSITY IS SIMILAR TO CORTICAL BONE. THE IMPLANTS ARE NOT RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    PT WAS COMPLAINING OF NUMBNESS IN THE LEFT FOOT AFTER A BILATERAL AT L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS MRW INTERVENTIONAL SPINE INC. 9045-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other