BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED THORACIC PROBE, BALL HANDLE (STAINLESS STEEL)

    MDR report key: 5078215 · Received September 15, 2015

    Report

    Report Number
    2027467-2015-00180
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 21, 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

    AN EVALUATION OF THE SUSPECT DEVICE REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. VISUAL INSPECTION OF THE RETURNED INSTRUMENT FOUND IT HAD FRACTURED AND SEPARATED AT THE 40MM DEPTH GROVE INDICATOR. 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 TIP OF AN ARSENAL PROBE BROKE OFF IN THE PATIENT DURING PEDICLE PREPARATION. THE DETACHED SECTION WAS REMOVED WITHOUT ISSUE AND CAUSED NO ILL EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609572 CURVED THORACIC PROBE, BALL HANDLE (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 87046-05 690169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other