BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORD 300 MM

    MDR report key: 15831053 · Received November 19, 2022

    Report

    Report Number
    3012447612-2022-00268
    Event Type
    Injury
    Date Received
    November 19, 2022
    Date of Event
    October 5, 2022
    Report Date
    February 16, 2023
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    QHP
    UDI-DI
    00880304865068
    PMA / PMN Number
    H190005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: QHP. 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.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D4: UDI NUMBER AND H3. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE CORD WAS FRACTURED IN MULTIPLE PIECES. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE CONTROL. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. 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. 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 A REVISION SURGERY WAS PERFORMED TO REPLACE A TETHER CORD THAT BROKE IN TWO PLACES POST-OPERATIVELY AFTER THE PATIENT WENT HORSEBACK RIDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A TETHER CORD THAT BROKE IN TWO PLACES POST-OPERATIVELY AFTER THE PATIENT WENT HORSEBACK RIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403504 CORD 300 MM THE TETHER - VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. NA 2966796 00880304865068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R