BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE PROBE - CURVED LUMBAR LENKE

    MDR report key: 12096617 · Received June 30, 2021

    Report

    Report Number
    3012447612-2021-00225
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 4, 2021
    Report Date
    July 2, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXB
    UDI-DI
    00889024009943
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. THIS REPORT IS RELAYING ADDITIONAL INFORMATION. DEVICE EVALUATION: VISUAL INSPECTION OF THE DEVICE SHOWS THE END HAS SNAPPED OFF. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. IT COULD ALSO BE ATTRIBUTED TO THE HARDNESS OF THE PATIENT'S BONE. DHR REVIEW PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS USING A LENKE PROBE IN AN AGGRESSIVE MANNER INTRA-OPERATIVELY WHEN CREATING THE PATHWAY FOR A PEDICLE SCREW DUE TO THE PATIENT'S DIFFICULT ANATOMY AND HARD BONE WHEN THE TIP OF THE PROBE BROKE OFF. THE SURGEON CHOSE TO LEAVE THE PIECE IN PLACE SINCE IT WAS ENCASED IN THE BONY ANATOMY AND WOULD NOT AFFECT THE PATIENT. A DIFFERENT PROBE WAS USED TO COMPLETE THE SURGERY WITHOUT FURTHER PATIENT IMPACTS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS USING A LENKE PROBE IN AN AGGRESSIVE MANNER INTRA-OPERATIVELY WHEN CREATING THE PATHWAY FOR A PEDICLE SCREW DUE TO THE PATIENT'S DIFFICULT ANATOMY AND HARD BONE WHEN THE TIP OF THE PROBE BROKE OFF. THE SURGEON CHOSE TO LEAVE THE PIECE IN PLACE SINCE IT WAS ENCASED IN THE BONY ANATOMY AND WOULD NOT AFFECT THE PATIENT. A DIFFERENT PROBE WAS USED TO COMPLETE THE SURGERY WITHOUT FURTHER PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989544 PEDICLE PROBE - CURVED LUMBAR LENKE PROBE HXB ZIMMER BIOMET SPINE INC. NA 63040721 00889024009943

    Patients

    Seq Age Sex Outcome Treatment
    1 Other