BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEDIGUARD TRI TIP 3.2 MM

    MDR report key: 2613752 · Received April 4, 2012

    Report

    Report Number
    3008102049-2012-00001
    Event Type
    Other
    Date Received
    April 4, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 4, 2012
    Manufacturer
    SPINEGUARD, SA.
    Product Code
    GWF
    PMA / PMN Number
    K030526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS THE INITIAL REPORT COMPILED BY THE IMPORTER, (B)(4), FROM INFO RECEIVED FROM THE DISTRIBUTOR, (B)(4). THIS REPORT IS THE INITIAL ANALYSIS REPORT (UNSIGNED) OF THE MATERIALS USED IN THE MFR OF THE LOT# 11194D0151. THERE HAVE BEEN NO REPORTS OF ANY PROBLEMS WITH THIS LOT. THE DESIGN HISTORY REPORT (DHR) FOR THE MATERIALS USED IN THE MANUFACTURE OF THE LOT# 11194D0151. THERE HAVE BEEN NO REPORTS OF ANY PROBLEMS WITH THIS LOT. THE UNIT IN QUESTION WILL BE RETURNED TO THE MFR FROM THE HOSPITAL AS SOON AS THE HOSPITAL HAS CONCLUDED ITS INTERNAL INVESTIGATION. IT IS EXPECTED THAT THE HOSPITAL WILL ALSO REPORT THIS EVENT TO FDA. AT THIS TIME, THE MFR IS KEEPING OPEN THE POSSIBILITY OF OPENING A CAPA ACCORDING TO THEIR QUALITY STANDARDS, PENDING THE OUTCOME OF ADD'L TESTING WHEN THE UNIT IS RECEIVED.

    Description of Event or Problem · 1

    DR. (B)(6) WAS PERFORMING A MULTIPLE LEVEL PEDICLE SCREW SURGERY. HE HAD SUCCESSFULLY COMPLETED 6 PEDICLES WITH THE PEDIGUARD AND ON THE 7TH PEDICLE THE TIP BROKE OFF AT THE CENTER PART OF THE VERTEBRAL BODY. THE PT'S BONE WAS STATED BY DR. (B)(6) TO BE VERY HARD. THE BROKEN TIP, ABOUT A FEW CENTIMETERS LONG, WAS UNRETRIEVABLE AND LEFT IN THE PT'S PEDICLE. THE TIP DID NOT PIERCE THROUGH THE ANTERIOR WALL. DR. (B)(6) THEN TOOK A STANDARD PROBE NOT A PG AND ADVANCED THE PORTION AS FAR ANTERIORLY AS COULD COMFORTABLY DO AND PUT A TITANIUM SHORTER SCREW IN SO AS TO NOT HAVE THE TWO METALS TOUCHING. AN X-RAY CONFIRMATION WAS PERFORMED TO SHOW THAT IT HAD NOT MIGRATED. THERE WAS NO CONSEQUENCE TO THE PT. THE HOSPITAL HAS RETAINED THE UNIT AND WILL GIVE IT BACK TO US ONCE THEY HAVE COMPLETED THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIGUARD TRI TIP 3.2 MM NERVE DETECTOR SYSTEM GWF SPINEGUARD, SA. P1-AU412 11194D0151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other