BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE PROBE - CURVED LUMBAR LENKE

    MDR report key: 16102563 · Received January 5, 2023

    Report

    Report Number
    3012447612-2023-00011
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 9, 2022
    Report Date
    June 12, 2023
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXB
    UDI-DI
    00889024009943
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE TIP OF LOT 112489 WAS FRACTURED 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 OFF-AXIS FORCES APPLIED DURING USE. DHR REVIEW AND RELATED ACTIONS: PER DHR REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMVIE CONTROL. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VITALITY PROBE BROKE INTRA-OP; THE TIP WAS RECOVERED USING PLIERS. THERE WAS A DELAY OF 5 MINUTES WITHOUT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VITALITY PROBE BROKE INTRA-OP; THE TIP WAS RECOVERED USING PLIERS. THERE WAS A DELAY OF 5 MINUTES WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644466 PEDICLE PROBE - CURVED LUMBAR LENKE PROBE HXB ZIMMER BIOMET SPINE INC. NA 112489 00889024009943

    Patients

    Seq Age Sex Outcome Treatment
    1 Male