BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED MODULAR AWL

    MDR report key: 1460454 · Received July 7, 2009

    Report

    Report Number
    9617544-2009-00283
    Event Type
    Malfunction
    Date Received
    July 7, 2009
    Date of Event
    June 19, 2009
    Report Date
    June 25, 2009
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HWJ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    METAL PEELED OFF FROM THE MANTIS INSTRUMENTS (3 PIECES) DURING THE SPINE SURGERY, METAL PIECES STUCK INSIDE L5 PEDICLE AND FINALLY FLUSHED OUT; X-RAY CHECKED THAT HAD BEEN CONFIRMED TO BE NO METAL RESIDUE OF THE INSTRUMENT REMAINED IN THE PT. SURGERY TYPE: PEDICLE SCREW FIXATION WITH PLIF CAGE L3, L4, L5 (NAVIGATION GUIDE, BRAINLAB, X-RAY ASSISTED) INSTRUMENT BROKEN: CAT. NO. 48281164 CANNULATED MODULAR AWL - METAL PEEL-OFF AT MOST DISTAL PART. CAT. NO. 48281165 CANNULATED MODULAR TAP 6.5MM - METAL PEEL-OFF AT MOST DISTAL PART. CAT. NO. 48237105 JAM SHIDI 10 GAUGE 5 INCH - BESIDE THE RIM OF THE HOLLOW TUBE BUT NOT IN THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED MODULAR AWL INSTRUMENT HWJ STRYKER SPINE BORDEAUX NA NIL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other