BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PROBE, STRAIGHT LENKE STYLE TIP

    MDR report key: 3827555 · Received May 22, 2014

    Report

    Report Number
    2027467-2014-00010
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE FOUND NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. COMPLETE DETAILS AVAILABLE IN ATTACHED EVALUATION SUMMARY.

    Description of Event or Problem · 1

    SURGEON HAD ENCOUNTER EXTREMELY HARD BONE, UPON REMOVAL IT WAS NOTICED THAT THE TIP OF THE PROBE HAD FRACTURED AND DETACHED FROM THE INSTRUMENT. THE DETACHED FRAGMENT REMAINS IMPLANTED WITHIN THE PATIENT'S THE S1 SACRUM. THERE ARE NO PLANS TO REMOVE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305640 BONE PROBE, STRAIGHT LENKE STYLE TIP LXH LXH ALPHATEC SPINE INC C62903-C14 C-6280107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other