BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS

    MDR report key: 2045642 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00080
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K062391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE CASE WAS AN L4-L5 TLIF WITH PEDICLE SCREW CONSTRUCT WITH A PEEK ROD ON ONE SIDE AND OUR BONE-LOK IMPLANT ON THE CONTRALATERAL SIDE. THE PATIENT MOST LIKELY HAD A SLIGHT PARS DEFECT ON THE SIDE THE BONE-LOK IMPLANT WAS PLACED WHEN THE ORIGINAL SURGERY WAS DONE. THE PEEK ROD ALLOWED FOR MICROMOTION, WHICH MOST LIKELY RESULTED IN THE PARS FRACTURE. THE BONE-LOK IMPLANT WAS NOTED TO BE IN GOOD POSITION ON THE PRE-OP CT SCAN (TAKEN RIGHT BEFORE THE REMOVAL) AND DURING THE REMOVAL ON (B)(6) 2009. EVENT CAUSED BY PRODUCT FROM OTHER MANUFACTURER. INITIALLY IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THAT THIS EVENT SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    PARS FRACTURED UNDERNEATH IMPLANT. EVENT CAUSED BY PRODUCT FROM OTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS MRW INTERVENTIONAL SPINE, INC. 9045-01 111207-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention