BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID DRILL - 12 MM

    MDR report key: 2883055 · Received December 18, 2012

    Report

    Report Number
    9617544-2012-00579
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ANALYSIS OF LABELING. RESULTS: THE BREAKAGE OCCURRED WHILE THE DRILL WAS BEING USED IN THE FIBULA OF THE PT'S LEG. THE IFU, (B)(4), STATES "STRYKER SPINE INSTRUMENTS MUST BE USED IN THE MANNER DESCRIBED IN THE SURGICAL TECHNIQUES BROCHURES PROVIDED BY STRYKER SPINE". THE REFLEX-HYBRID SURGICAL TECHNIQUE STATES THAT "THE ACP SYSTEM ARE INTENDED FOR ANTERIOR INTERVERTEBRAL SCREW FIXATION OF THE CERVICAL SPINE FROM C2 TO T1". CONCLUSION: THE REPORTED EVENT RELATES TO AN OFF-LABEL INDICATION. THE REFLEX-HYBRID DRILL IS INTENDED FOR USE IN ANTERIOR INTERVERTEBRAL CERVICAL FIXATION OF THE CERVICAL SPINE FROM C2 - T1.

    Description of Event or Problem · 1

    DURING SURGERY WHEN THE SURGEON DRILLED THE FIBULA FOR BONE TRANSPLANTATION WITH THE DRILL, IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX-HYBRID DRILL - 12 MM INSTRUMENT LXH STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK