BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PROBE CURVED LENKE

    MDR report key: 4934555 · Received July 21, 2015

    Report

    Report Number
    3005739886-2015-00058
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    ENGINEERING REVIEW NOTED THE PSSPCL CURVED LENKE BONE PROBE FRACTURED DURING THE INTENDED USE OF THIS INSTRUMENT. REVIEW OF THE COMPLAINT SUMMARY INDICATES THAT THE BONE PROBE WAS REPEATEDLY STRUCK WITH A MALLET TO ADVANCE THE PROBED THROUGH VERY HARD BONE. THE EXCESSIVE FORCE OF IMPACTION WAS THE PROBABLE CAUSE OF THE FAILURE OF THE TIP AND CAN BE ATTRIBUTED TO MISUSE. REVIEW OF MANUFACTURING HISTORY RECORDS FOUND A TOTAL OF FIVE (5) PIECES OF THIS LOT WERE RELEASED FOR DISTRIBUTION ON APRIL 30, 2008 WITH NO DEVIATION OR ANOMALIES. A TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT IDENTIFY A TREND OF MISUSE FOR THIS PART NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED (B)(6) 2015, ON A PATIENT WITH VERY HARD BONE, THE DOCTOR HAD TO TRIKE THE BONE PROBE REPEATEDLY WITH A MALLET, RESULTING IN BREAKAGE OF THE TIP OF THE PROBE. APPROXIMATELY 20MM OF THE TIP REMAINED IN THE PEDICLE. THE DOCTOR USED A TREPHINE TO BURR AROUND THE TIP IN ORDER TO GRAB AND PULL IT OUT. A DELAY OF APPROXIMATELY 40 MINUTES RESULTED WHILE A TOOL WAS LOCATED AND STERILIZED TO BE USED TO PULL THE TIP OUT OF THE BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED (B)(6) 2015 ON A PATIENT WITH VERY HARD BONE, THE DOCTOR HAD TO STRIKE THE BONE PROBE REPEATEDLY WITH A MALLET, RESULTING IN BREAKAGE OF THE TIP OF THE PROBE. APPROXIMATELY 20MM OF THE TIP REMAINED IN THE PEDICLE. THE DOCTOR USED A TREPHINE TO BURR AROUND THE TIP IN ORDER TO GRAB AND PULL IT OUT. A DELAY OF APPROXIMATELY 40 MINUTES RESULTED WHILE A TOOL WAS LOCATED AND STERILIZED TO BE USED TO PULL THE TIP OUT OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473172 BONE PROBE CURVED LENKE HXB HXB PRECISION SPINE, INC. 590223D08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention