BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LXH

    MDR report key: 5021521 · Received August 21, 2015

    Report

    Report Number
    2027467-2015-00171
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AT THIS TIME. THE INSTRUMENT IN QUESTION HAS NOT BEEN RETURNED NOR HAS THE IDENTIFYING PART AND/OR BEEN PROVIDED. A PREVIOUS INVESTIGATION FOR THIS TYPE OF EVENT FOUND THAT THE INSTRUMENT FAILED DUE TO EXCESSIVE LATERAL BENDING/FATIGUE STRESS RELATED EITHER TO THE PATIENT OR CLINICAL FACTORS/CIRCUMSTANCES. ALTHOUGH NO PRODUCT PROBLEM HAS BEEN IDENTIFIED, ENGINEERING HAS UPDATED THE PRINTS TO FURTHER IMPROVE THE DESIGNS OF ALL ARSENAL PROBES. THE MATERIAL WILL BE UPDATED TO 465 SS AND THE INDICATING GROVE FEATURE WILL BE MANUFACTURED WITH A SHALLOWER DEPTH.

    Description of Event or Problem · 1

    THE ARSENAL PROBE BROKE DURING USE. THE DETACHED SECTION WAS REMOVED FROM THE PATIENTS PEDICLE WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554736 LXH LXH ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other