BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACK PAK LITE

    MDR report key: 1237403 · Received November 11, 2008

    Report

    Report Number
    3003855635-2008-00004
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    LXH
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN RASP RETURNED TO QC FOR EVAL. NO ANOMALY COULD BE FOUND IN THE DHR/DOCUMENTATION AND INSPECTION OF THE TOOL WHICH COULD HAVE CONTRIBUTED TO THE EVENT. TOOL PROVIDED TO THE ENGINEERING DEPT. FOR FURTHER EVAL.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT DOCTOR WAS CLEANING L5-S1 DISC SPACE. NORMAL PROCEDURE, AND JUST COMPLETED L3-4 AND L4-5. NO SIGNIFICANT EFFORT. HE WAS LEVERAGING RASP AND NOTICED WHEN HE BROUGHT IT OUT THAT THE RASP WAS BROKEN. DELAY OF SURGERY OF NO MORE THAN 15 MINUTES TO RETRIEVE THE BROKEN PIECE. NO PT CARE ISSUE. PT DID WELL POST OP WITHOUT ANY APPARENT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACK PAK LITE RASP - ORTHO. MANUAL INST. [888.4540] LXH ATLAS SPINE INC. 00418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention