BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT ADJUSTER

    MDR report key: 3842858 · Received June 2, 2014

    Report

    Report Number
    1030489-2014-02682
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 3, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUALLY CONFIRMED THE INSTRUMENT TIP HAS BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL MOVEMENT, CONSISTENT WITH TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, THE TIP OF THE ADJUSTER BROKE WHILE TRYING TO RETRIEVE A PREVIOUSLY IMPLANTED TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320845 STRAIGHT ADJUSTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDICS NA IT06H030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other